15th Pharmacovigilance 2018
Offering our customers the knowledge and connections for a profitable business



    KARSTEN LOLLIKE Novo Nordisk


    RENE HALTINER Conceptual Process Solutions / F. Hoffmann-La Roche






    DAVID J LEWIS Novartis


    TANJA PETERS Boehringer Ingelheim


    MICHAEL BEAN Janssen Pharmaceutical




    HELEN MCASKILL Isle of Man Government






    MICHAEL RICHARDSON Bristol-Myers Squibb


    RUDI SCHEERLINCK Nestle Skin Health


    SUMIT MUNJAL Takeda Pharmaceuticals




    ANGUS MCCULLOCH Bioclinica


    ULRICH VOGEL Boehringer Ingelheim


    JACKIE ROBERTS Accord Healthcare


    STEINAR MADSEN Norweigen Medicines Agency




    DAVID GILLEN Vertex Pharmaceuticals


    ALINA TUDOR Norgine


    HEINZ WEIDENTHALER Bavarian Nordic




    MIRCEA CIUCA Vifor Pharma


    KAREN CHENG Pfizer


    G. NARAYANAN Voisin Consulting Life Sciences


    JORGE GONZALEZ BORROTO Ferrer Internacional


    ANDREA MAULWURF Allergy Therapeutics




    CHETAN SHATAPATHY AstraZeneca (Director, Sanjeevani Pharma)


    SANDY EISEN Frontline Pharma Consulting


    BARBARA DAWSON Dawson & Co Consulting


    HILARY JONES Bristows

21st & 22nd February 2018, Holiday Inn, Kensington High Street, London UK

“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”

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The global pharmacovigilance (PV) market is expected to reach USD 10.27 billion by 2025. The market is expected to witness growth at 13.1% CAGR owing to Increasing incidence of ADR is key driver for the growth of pharmacovigilance market. As of 2015, the U.S. FDA received approximately 253,017 serious adverse events and 44,693 deaths associated with adverse drug reactions (ADRs). This shows the potential demand for implementing safety and pharmacovigilance services over the forecast period. The rapid induction in the market throws up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. New drug approvals by the FDA have risen to near-record levels in the past two years: of the 45 medicines approved by the agency in 2015, 60 per cent went through one of the agency’s fast-track processes. The number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs.

15th Annual Pharmacovigilance 2018 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.  The entire program will cover the detection, analysis and prevention of adverse drug reactions.  It will be studied with the help of case studies and industry experiences. This conference will help the drug safety representatives from the pharmaceutical industry and quality research organisations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others to gain a greater understanding of new and existing pharmacovigilance requirements, and to improve their organisation’s compliance with pharmacovigilance requirements. Also it can help you control your product's lifecycle, your patient's trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting pharmacovigilance development.

It gives me great pleasure in welcoming all of you to the Virtue Insight’s 15th Pharmacovigilance 2018.  I wish and pray that all our efforts will be beneficial to our industries and to our country at large.


  • Pharmacovigilance in 2020 - future horizons and efficiencies
  • Updates towards of legislation, policies, systems, technology, communication strategies and best practice in PV
  • Possible effects of Brexit on Pharmacovigilance
  • Strategies for best practice in bene t-risk management
  • Market analysis – What is our current stand? – Moving towards the new successful PV era
  • Implementing risk minimization procedures - Making sure we succeed
  • Examining developments in GVP measures and status of the new Module VI
  • Improving in signal management and their implications
  • Latest updates and hot topics relating to the role of the QPPV
  • Challenges and Opportunities to optimize the overall PV ecosystem for maximum benefit
  • Safety information for signal detection and management
  • Medical devices – Increasing safety perspective
  • Case studies from various countries on the PV frameworks around the world
  • Good Clinical Practices and Good Pharmacovigilance practices
  • IT and new technologies for improvement of PV and clinical research
  • Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
  • Patient centric approach to help improve patient safety
  • Outsourcing activities - How to set it right?
  • PV Audit & inspections - preparation, implementation and lessons to be learnt
  • Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
  • How to involve patients better to develop drugs
  • The developing regulatory framework in advanced and developing markets – EU, USA & ROW
  • Accelerating new medicine introduction in developing world & overcoming challenges
  • Be part of a major networking opportunity



CEO’s, CTO’s, CIO’s, Presidents, VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:

  • Pharmacovigilance
  • Pharmacoepidemiology
  • Pharmacogenomics
  • Drug/Product Safety
  • Drug Development
  • Information and Clinical Data Management
  • Clinical Pharmacology
  • Clinical Safety
  • Periodical safety update Reports
  • Risk Management
  • Research & Development
  • Quality Assurance
  • Patient Safety
  • Signal Detection
  • Safety Surveillance
  • Outcomes Research
  • Data Analysis
  • Epidemiology
  • Medical Affairs
  • Regulatory Affairs and Compliance
  • Information technology
  • Sales and Marketing 



15th Pharmacovigilance 2018 “Latest developments in pharmacovigilance, drug safety and risk management"

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway.  Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins.

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:30 – Chairperson opening remarks
SUSAN WELSH, Chief Safety Officer, CSL Behring


09:40 – PV considerations in Patient Support Programmes (PSPs), and other External Engagement Activities

  • Why should the role of safety/PV colleagues be in PSPs, Market Research, and other non-study outward-facing activities?  What are the regulatory expectations?
  • How to effectively partner with other colleagues to mitigate unexpected safety-related issues.
  • How to promote quality of safety-related information from these programmes

PHILIP EICHORN Senior Director (Worldwide Safety and Regulatory), Pfizer

10:20 – Crisis management within drug safety

  • Handling of a safety crisis
  • Decision process – relevant parties
  • Communication - Authorities, DHCP letter, stock markets, internally
  • Role of legal
  • Execution
  • Conclusions / Discussion

KARSTEN LOLLIKE, Corporate Vice President and QPPV, Novo Nordisk

10:50 – Morning Coffee/Tea & Discussion

11:10 – Solution Provider Presentation
For sponsorship opportunities please contact info.uk@virtueinsight.com

11:30 – Developing a PV Automation Path that delivers for your organization

  • Where do you begin
  • Fit for purpose design
  • What are the available technologies
  • Are there levels of adoption
  • Building an Automation culture into your operation

ANGUS MCCULLOCH, Senior Vice President Pharmacovigilance, Bioclinica


11:50 – Keynote Panel Discussion: Challenges and Opportunities - Optimize the overall PV ecosystem for maximum benefit

  • Discuss on the possible impacts of Brexit
  • Staying ahead in the race - Update on PV in EU, USA & RoW - Current trends for PV, and new and future guidelines
  • Develop measures that achieve a more patient centric approach to drug safety
  • Engaging Key Stakeholders
  • Technology impact - The role of social media
  • Explore long term PV visions, future directions of the ‘PV world’, and potential impact on the role of QPPV
  • Best practices for license partner audits
  • Legislation update worldwide

RUDI SCHEERLINCK, Head Pharmacovigilance Risk Management, Nestle Skin Health

MICHAEL RICHARDSON, VP International GPV&E and EU QPPV, Bristol-Myers Squibb
TANJA PETERS, Global Head of PV Intelligence, Deputy EU QPPV, Boehringer Ingelheim
RICARDA TIEMEYER, Head of Drug Safety & PoC Medical Information, Roche

JACKIE ROBERTS, Executive Director Regulatory, Pharmacovigilance and Medical, Accord Healthcare

12:30 – Networking luncheon


13:40 – Panel Discussion - Future of PV - Where are we heading?

  • Strategies for best practice in benefit-risk management
  • Using technology to enhance interactive connection with patients
  • Providing valuable insight into the functioning of the PRAC
  • Who are the most important stakeholders and how does the PRAC cooperate with them?
  • Latest updates and hot topics relating to the role of the QPPV

MIRCEA CIUCA, Global Head Medical & Clinical Drug Safety, Vifor Pharma

VICKI R EDWARDS, Vice President, Pharmacovigilance Excellence and QPPV, Abbvie
SUMIT MUNJAL, Global Director, Pharmacovigilance & EU Region Medical Advisor - Lead Oncology Portfolio, Takeda Pharmaceuticals
DAVID J LEWIS, Senior Adviser Pharmacovigilance, Novartis
ANDREA MAULWURF, Head of Pharmacovigilance, EU-QPPV, Allergy Therapeutics
DAVID GILLEN, VP and Head of International Medical Affairs, Vertex Pharmaceuticals


14:20 – Clinical data strategy and analytics:

  • Enabling Data Driven Trials
  • Centralised monitoring
  • Analytics to drive better decisions in clinical development
  • Analytics linked to strategy & execution
  • Quality, Risk, Analytics, and Speed: Industry trends and the impact on the direction of clinical data management

15:00 – Pharmacovigilance in 2020 - future horizons and efficiencies in data acquisition, evaluation and risk management

  • Market analysis – What is our current stand?
  • Initiating a new product portfolio and PV implications to enable a successful launch into market
  • An overview of pharmacovigilance, pharmacoepidemiology, pharmaceutical risk management, and medication error prevention.
  • Does the shift towards emerging markets pose a risk to drug safety and biased data reports?

ALINA TUDOR, Associate Director, Senior PV physician/Deputy EU QPPV, Norgine

15:40 – Afternoon Tea/Coffee

16:00 – Brexit and the impact on Pharmacovigilance

  • Impact of Brexit on QPPV
  • Impact of Brexit on EMA
  • Impact of Brexit on Eudravigilance and XEVMPD
  • Other possible implications

16:30 – Automated PV data processing and its game changing prospect
RENE HALTINER, Managing Director / Senior PV Strategy Lead, Conceptual Process Solutions / F. Hoffmann-La Roche

17:00 – Chairperson’s closing remarks and end of conference

17:10 – 18:10 – Networking Drinks Session

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:30 – Chairperson opening remarks
SUSAN WELSH, Chief Safety Officer, CSL Behring


09:40 – Integrating Signal and Risk Management from a Small to Medium sized company’s perspective

  • Summary of available systems
  • First learnings from upgraded EudraVigilance platform
  • Aligning the processes of Signal management and Risk management
  • Can small companies learn from large ones or vice-versa?

HEINZ WEIDENTHALER, Director Pharmacovigilance, QPPV, Bavarian Nordic


10:20 – Changes in the PV world to accommodate combination product safety requirements

  • Combination product safety reporting poses some unique challenges for the PV organization at a strategic and at an individual report level
  • Simple and Effective processes including organizational changes to adapt to the needs support a timely and compliant implementation
  • Use of scenarios to gain the knowledge with real-world examples help audience find solutions for these challenges.


11:10 – Keynote Panel Discussion – Enhancing communications between - Sponsor – Site – CRO & Patients

  • Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
  • How improved Sponsor-Site communications could change the clinical research industry
  • Importance of involving patients in the communication
  • Communication best practices
  • Level of training and preparedness
  • Putting communicatons to actions
  • Considerations for good PV outsourcing practices

CHETAN SHATAPATHY, Principal Safety Physician, AstraZeneca (Director, Sanjeevani Pharma)

FRANCK SCHWARTZ, QA Global Inspection, Intelligence Lead - Compliance and Regulatory Affairs, Novartis
HELEN MCASKILL, Interim Head of Research and Development at Department of Health,
Isle of Man Government
SANDY EISEN, Chief Medical Officer, Frontline Pharma Consulting
BARBARA DAWSON, Pharmacovigilance Consultant, Dawson & Co Consulting

11:50 – PV in low & middle income countries & how high income countries and the industry can do more to improve patient safety in these resource scarce settings

MICK FOY, Group Manager, Vigilance Intelligence and Research Group Vigilance and Risk Management, MHRA

12:20 – Solution Provider Presentation
For sponsorship opportunities please contact info.uk@virtueinsight.com

12:40 Networking luncheon


13:30 – Panel Discussion - Implementing risk minimization procedures - Making sure we succeed

  • Implementation and maintenance of RMP’s – Overcoming its challenges
  • New tools in drug safety and optimizing benefit t risk management
  • What should we learn from previous experiences?
  • New approaches to managing benefit-risk
  • Making the RMP a useful tool in pharmacovigilance

SUSAN WELSH, Chief Safety Officer, CSL Behring

JOHN SOLOMON, Head of Pharmacovigilance - UK & Ireland, Sanofi
JORGE GONZALEZ BORROTO, Pharmacovigilance Officer / Nonclinical Toxicology Expert,
Ferrer Internacional

KAREN CHENG, Safety Risk Lead, Pfizer

KATHRIN WAWRA-HEHENBERGER, Director, Clinical Safety Physician, CSL Behring


14:10 – PV Audit & Inspections - Preparation, implementation and lessons to be learnt

  • Major and a vital role - Monitoring PV compliance
  • PV Inspection readiness: What to expect? How ready can we be?
  • PV Compliance: PV is at the Center but cannot do it alone. How to mobilize internal and external stakeholders?
  • Risk based selection criteria for auditing
  • Methodologies, scope and oversight
  • Relationship to other GxPs

MICHAEL BEAN, Senior Director, Regulatory Compliance R&D, Janssen Pharmaceutical

14:50 – Case study: EudraVigilance Monitoring

  • What has changed since Nov 22, 2017
  • Transitional arrangements
  • EVDAS access for MAHs
  • Initial learning and practical considerations

ULRICH VOGEL, Head Strategic Data Analysis, Global Pharmacovigilance, Boehringer Ingelheim

15:20 – Afternoon Tea/Coffee

15:40 – Why does pharmacovigilance sometimes fail and where
could the fault lie?

  • Risk blindness  - industry or drug authorities?
  • It’s not my fault – but whom to blame?
  • Hard to detect adverse reactions
  • Do we learn from previous experiences?

STEINAR MADSEN, Medical Director, Norweigen Medicines Agency


16:20 – Panel Discussion: Keeping abreast with the changing regulations of PV

  • Key current changes and their impact on current PV
  • Current PV practices in the EU & US
  • Enhancing communication between regulators, regional authorities and patients be further enhanced?
  • Examining developments in GVP measures and status of the new Module VI
  • Market access and complying with PV regulations
  • Moving positively towards the new era

G. NARAYANAN, Vice President, Disruptive Biologics, Voisin Consulting Life Sciences

YUUNG YUUNG YAP, Senior International Regulatory Counsel, EU and International Regulatory Law, Pfizer
DAVID JEFFERYS, Sr. VP Regulatory, Eisai

HILARY JONES, Of Counsel, Bristows

17:00 17:10 – Chairperson’s closing remarks and end of the conference


Vice President, Pharmacovigilance Excellence and QPPV



Corporate Vice President and QPPV

Novo Nordisk


Managing Director / Senior PV Strategy Lead

Conceptual Process Solutions / F. Hoffmann-La Roche


Head of Pharmacovigilance - UK & Ireland


John Solomon is the UK/IE MCO Head of Pharmacovigilance responsible for leading the post authorisation drug surveillance activities for the broad Sanofi portfolio including Innovative, Generics, Biologics and Vaccines products.

Prior to joining Sanofi in 2005 John was the Head of Drug Safety Europe at MDS Pharma Services.Qualified in medicine, John has worked for over 16 years in the industry spending most of these years in clinical drug safety and post marketing drug surveillance activities.

Other industry related experience includes pharmaceutical marketing and global Clinical research programmes from within the Pharmaceutical industry and Clinical Research Organisation sector respectively.

John is currently a Pharmacovigilance representative on UK Pharmaceutical and Self-care industry trade associations.

John is especially committed to transparency around patient centric Pharmacovigilance and the Commercial value of effective Pharmacovigilance.


Senior International Regulatory Counsel, EU and International Regulatory Law



Senior Adviser Pharmacovigilance



Global Head of PV Intelligence, Deputy EU QPPV

Boehringer Ingelheim


Senior Director, Regulatory Compliance R&D

Janssen Pharmaceutical

Michael graduated from Nottingham Trent University with a Bsc (Hons) in Applied Biology. Somehow after university he ended up working in the exciting world of quality assurance, fulfilling a life long ambition.

His first position was at HLS, where he spent four years in the QA department as a GLP Auditor. Michael then moved to be a GLP QA Advisor at CTL then part of Zeneca. But as usual in the pharmaceutical industry while sitting at the same desk he worked for AstraZenca and Sygenta. His next move was to Novartis as a Pharmacovigilance Auditor where he spent two working in that developing area of audits.

Michael then joined the MHRA in May 2003 as a Pharmacovigilance Inspector where he made a significant contribution to the development of the statutory ph programme, training and recruitment of new inspectors, organising symposia and providing training to other Competent Authorities concerning Pharmacovigilance inspections. Michael was the Operations Manager and Senior Inspector responsible for management of Pharmacovigilance Inspectors prior to leaving in February 2008.

Michael moved back into industry as Regional Director in Pharmacovigilance Quality Assurance and is currently Senior Director, Regulatory Compliance Bioresearch Quality & Compliance at J&J.


Chief Safety Officer

CSL Behring


Interim Head of Research and Development at Department of Health

Isle of Man Government


QA Global Inspection, Intelligence Lead - Compliance and Regulatory Affairs


Franck Schwartz has got a MD degree on 1989. After having practiced the medicine as a general practitioner for two years, he joined the Ipsen Group in 1992. Being first a project manager in clinical development, he moved to Quality Assurance and headed the International Quality Assurance Department covering GCP, PV. GLP and computerized system validation for more than 12 years.

As Senior Director Safety & Compliance, he managed both the QA and Global Pharmacovigilance Departments for three years. He then moved to the French Regulatory Agency as Pharmacovigilance inspector. He joined Novartis in 2014 as Senior Compliance Professional in the Compliance & Inspection Department in Basel. In this role, he managed the PV system internal audits as well as the compliance metrics in the Pharma Division.

Franck Schwartz is a member of the Research Quality Association (RQA) as well as the US Society of Quality Assurance (SQA).


Head of Drug Safety & PoC Medical Information


Born in Munich, Ricarda Tiemeyer started her studies in biology at the Munich Ludwig Maximilians University in 2006 with the main focus on Cell biology, Neuroscience, Pharmacology and Toxicology. In 2011, after her graduation and fascinated about the fast changing and innovative scientific environment she moved to Switzerland to start her career in the Medical Department at Roche. Ricarda became the Head Drug Safety & Country PoC Medical Information at Roche Pharma (Switzerland) AG after multiple years of experience at Roche in the field of pharmacovigilance and compliance.


VP International GPV&E and EU QPPV

Bristol-Myers Squibb

Michael Richardson has over 30 years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and Development in Asia. Currently International Head of Bristol Myers Squibb’s Pharmacovigilance Function and Eu QPPV. Prior to this role he headed their Development and Medical Organisation across Asia Pacific and Eli Lilly’s before that in the same Role. Before joining Lilly he worked in a joint venture in Japan, Fujisawa-Fisons setting up their development and quality control organisations and prior to that with Organon laboratories in the UK.

After qualifying in Medicine he completed a postgraduate studies in Obstetrics and Gynaecology in the UK and South Africa. He spent a year as Physician and Deputy Leader to the South African Antarctic expedition Antarctica. He has extensive experience in Latin America, Europe, Middle East, Japan and Asia Pacific. He has successfully managed and built Life Science organisations in over 30 countries with diverse cultural groups.


Head Pharmacovigilance Risk Management

Nestle Skin Health

Rudi Scheerlinck is an MD (VUB; Brussels) who holds a Post-graduate in Pharmacology and Pharmaceutical Medicine (ULB; Brussels) and an executive MBA in International Management (SBS Swiss Business School, Zurich).
He has a broad experience in pharmacovigilance, including signal detection, medical analysis, management of safety issues, process improvement, and change management.
Rudi is a former Deputy EU QPPV and set up and led medical evaluation & risk management teams at UCB, GSK Biologicals, and Novartis Oncology, covering products in several therapeutic areas in pre- and post-marketing.  He was Head Global Drug Safety at Basilea where he developed a compliant PV system.
Currently, Rudi is global Head Pharmacovigilance Risk Management at Nestlé Skin Health, where he is responsible for case processing, aggregate reports, signal detection, signal evaluation, and risk management.


Global Director, Pharmacovigilance & EU Region Medical Advisor - Lead Oncology Portfolio

Takeda Pharmaceuticals

Dr Sumit Munjal, a physician by training and an Indian by background has been associated with Academic organizations such as London School of Hygiene & Tropical Medicine, Faculty of Pharmaceutical Medicine of the Royal College of Physicians and DSRU Southampton;

Government organizations such as NHS UK and MHRA;

And Pharmaceutical industry such as Johnson & Johnson, Millennium Oncology Pharmaceuticals Inc, Nycomed and Takeda Pharmaceuticals.

He is keen and remains committed to promote public health, patient safety and meet healthcare needs around the globe. He is currently based out of Central London.

Nov 2015, Dr Sumit Munjal


Group Manager, Vigilance Intelligence and Research Group Vigilance and Risk Management


Mick Foy has been with the MHRA for more than 30 years, he has been manager of the Vigilance Intelligence and Research Group for 10 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is also responsible two large European projects to improve drug safety monitoring. The EC funded SCOPE (Strengthening Collaborations to Operate Pharmacovigilance in Europe) Joint Action aims to improve the pharmacovigilance capabilities of national regulators in Europe, and the Innovative Medicines Initiative funded WEB-RADR (Recognising Adverse Drug Reactions) project seeks to deliver mobile Apps for reporting ADRs and to utilise social media for drug safety purposes.

Mick also leads the MHRA’s international strategy with regard to pharmacovigilance capacity building.

Mick is also a member of the MedDRA Management Board


Senior Vice President Pharmacovigilance



Head Strategic Data Analysis, Global Pharmacovigilance

Boehringer Ingelheim

•    Trained as medical doctor
•    Joined PV in 2002
•    From 2004 – 2011, had various medical roles in Global PV risk management
•    Since 2012, Head of Global PV data analysis team, providing strategic support to risk management
•    Accountabilities: Process ownership for signal management, analytical standards applied to PV data
•    Member of CIOMS VIII
•    Research interests: Business intelligence frameworks in safety signal detection and trending, causal inference from complex datasets, structured discussion of benefits and risks


Executive Director Regulatory, Pharmacovigilance and Medical

Accord Healthcare

Dr Jackie Roberts is the Executive Director responsible for regulatory, PV and medical at Accord Healthcare Ltd in the UK, she is also the QPPV for Actavis UK Ltd. Jackie has a PhD in clinical pharmacology from Imperial College, London and an MBA from Warwick Business School. She has many years experience within the pharmaceutical industry including time spent at the MHRA, a CRO and the NHS. Accord Healthcare Ltd is a fast growing generic pharmaceutical company with a broad portfolio of products which covers most therapeutic areas.


Medical Director

Norweigen Medicines Agency

Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency. He has been working with generic substitution since it was introduced in Norway in 2001 and with biosimilars since 2006. He is member and previously chairman of the committee for generic substitution at the Agency. Dr. Madsen is also engaged in the drug information service, with a special interest in the safe and cost-effective use of drugs. He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology.


Senior Director (Worldwide Safety and Regulatory)


Dr Eichorn did his medical training in the US and practiced general adult medicine in the outpatient and hospital settings for 10 years before joining the pharmaceutical industry.  He joined Pfizer (UK) in 2012 and since then has served a number of roles in the safety, risk management and regulatory documentation functions.  For the past 2 years his major focus has been providing cross-portfolio guidance on the RMP within the safety line.


VP and Head of International Medical Affairs

Vertex Pharmaceuticals


Associate Director, Senior PV physician/Deputy EU QPPV



Director Pharmacovigilance, QPPV

Bavarian Nordic

Heinz Weidenthaler graduated in medicine in 2000, and holds a M.D. degree since 2003. Initial clinical training in psychiatry, then started in the pharmaceutical industry in 2002, when he joined Novartis (Nuremberg, Germany) as Medical Safety Expert. He worked there until 2009 in the German country affiliate, including team lead for respiratory and psychiatric products, additional roles as Safety Responsible Person for Medical Devices and local manager for implementation of Risk Management Plans. In 2009, he took over as QPPV and Director Pharmacovigilance at Medigene AG in Martinsried, Germany, where he was responsible for all pharmacovigilance aspects of marketed and development products. Since 2013 he is QPPV and Director Pharmacovigilance at Bavarian Nordic GmbH, Martinsried, Germany. Responsibility includes pharmacovigilance for vaccines for infectious diseases and tumor vaccines, approved and under clinical development.


Director, Clinical Safety Physician

CSL Behring


Global Head Medical & Clinical Drug Safety

Vifor Pharma

Mircea Ciuca, MD is Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance. Dr. Ciuca has about 12 years experience in drug safety. Prior to joining Vifor Pharma he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical-scientific department of a medium-sized CRO in Rotterdam.

He graduated from the University of Medicine and Pharmacy in Bucharest Romania. He specialized in Emergency Medicine and later in Obstetrics & Gynecology. He was involved in clinical practice and academic teaching for about 12 years.


Safety Risk Lead


Karen Cheng is a physician with approximately 12 year’s experience in Global Pharmacovigilance; working at AstraZeneca, Boehringer Ingelheim, Fishawack Archimed and is currently Senior Director Safety Risk Lead in Anti-infectives at Pfizer. She has extensive experience as the pharmacovigilance and cross functional safety management team lead for products at all stages of the clinical development and post-marketing lifecycle, including products with high profile safety concerns. In addition, she has experience of submissions both within the industry and as a Clinical Assessor at the MHRA, has briefly worked in a phase I/II unit in a Biotech start-up and joined the industry with 10 years clinical experience in Emergency Medicine, Trauma, Surgery and Transfusion Medicine in the National Health Service in the UK. Karen is a fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom and is a member of the Good Pharmaceutical Medical Practice Support Network which provides guidance and direction to pharmaceutical physicians who face ethical or medical dilemmas in their practice.


Vice President, Disruptive Biologics

Voisin Consulting Life Sciences

Dr Narayanan provides leadership in the area of complex and disruptive biologics such as Cell and Gene therapies, including guidance on product development and regulatory strategy and in the global effort of rationalising the development process through which such disruptive biologics can be brought to patients faster and more efficiently.

Narayanan was a senior regulator at the UK MHRA for nearly 12 years as an expert medical assessor, and 4 years as Manager of the Biologicals Unit. He was a member of the Committee for Advanced Therapies (EMA/CAT 2009 – 2013), Scientific Advice Working Party (CHMP/SAWP 2009 - 2013) representing  EMA/CAT, Biosimilar Working Party (EMA/BMWP) and Gene Therapy Working Party (CAT/GTWP).

Narayanan qualified as a physician, and has dual specialist postgraduate qualification in general internal medicine and pharmaceutical medicine. He is currently on the Scientific Editorial Board of Human Gene Therapy Clinical Development journal and is a Review Editor of Regulatory Science section of Frontiers in Medicine, and is based in the UK.



+44 (0) 1276 671166


Pharmacovigilance Officer / Nonclinical Toxicology Expert

Ferrer Internacional


Head of Pharmacovigilance, EU-QPPV

Allergy Therapeutics


Sr. VP Regulatory


David is currently Senior Vice president in Eisai , responsible for Global Regulatory, Government Relations , Public Affairs and Product Safety . After qualifying in medicine, he practised as a physician and cardiologist, with additional interests in metabolic medicine and clinical toxicology . He spent 21 years as a senior regulatory in the UK and Europe . He was executive director of licensing in MCA , CPMP member  , chairman of the MRFG and PER committees. He was CEO and Director of the UK Medical Devices Agency  and on the creation of the MHRA acting joint chief executive . He worked on secondment at the EMEA /EMA on benefit risk methodologies.

Since 2005 he has worked for Eisai, currently he is also chairman of the ABPI regulatory committee and a member of the Innovation Board .Within Efpia he chairs the Regulatory Committee and sits on the International Regulatory Board.

He also co -chairs the IFPMA regulatory policy , standards and technical committee ( RPTS). He is a past chairman of both RAPS and TOPRA and currently serves as the external relations adviser to the TOPRA Board.

He is a past chairman of the CMR Advisory Board and currently sits as a member of the CIRS Scientific advisory Council .


Principal Safety Physician

AstraZeneca (Director, Sanjeevani Pharma)

Dr. Chetan Shatapathy is an experienced pharmaceutical physician who has worked in several marquee pharmaceutical companies as a pharmacovigilance and risk management physician, in global roles of increasing seniority and as a specialist consultant. He both qualified as a Medical Doctor and completed his Masters Degree in Clinical Physiology from one of India’s premier medical institutions, the Jawaharlal Institute of PG Medical Education and Research in Pondicherry. Thereafter he obtained a PhD Degree in Human Embryonic Stem Cell Biology from Kings College London, University of London in 2010, where his research focussed on the derivation of cardiovascular progenitor cells. Since joining the pharmaceutical industry, Chetan has worked across different therapeutic areas in companies such as Eli Lilly, Takeda, Johnson and Johnson and GSK, in pharmacovigilance and clinical development, and has extensive experience in developing strategy, regulatory submissions, all aspects of pharmacovigilance, benefit-risk planning and lifecycle management of products, including leading the safety team in regulatory submission for new indications and line extensions at FDA and EMA. Currently he is working as the Principal Pharmacovigilance Physician in the Oncology Therapeutic Area at AstraZeneca and is based out of Cambridge.

Chetan is a passionate sports fan who played football and basketball for his University, and keenly follows a wide variety of different sports. He works closely with children’s disability charities, is an avid quizzer, and speaks/understands 9 different languages. Chetan is happily married to Neena, a trained architect and homemaker, and they are parents to a football and music-mad 7 year old, Shrimukund.


Chief Medical Officer

Frontline Pharma Consulting

(Previously Chief Medical Officer, Teva Europe, 2006 – 2011)

Dr Eisen graduated from Cambridge University in 1980 and studied clinical medicine at St Bartholomew’s Hospital Medical School in London.  He has postgraduate medical qualifications in Surgery and in Pharmaceutical Medicine and now has over 25 years’ experience in pharmaceutical regulation and pharmaceutical medicine.  He has worked in several senior positions in both Government and the Pharmaceutical Industry, most recently having been Chief Medical Officer for Teva Pharmaceuticals Europe for 5 years.

In 2011 he set up his own Company, Frontline Pharma Consulting Ltd providing independent advice to pharmaceutical and financial companies on all aspects of research, pharmaceutical regulation and drug safety, and covering innovative products, biosimilars and generics in all therapeutic areas.  He also works on contract in interim senior management roles, including Medical Director, Clinical Research Director and as a Senior Safety Physician/QPPV.

Contact details:



+44 7921 495663 (mobile)

+44 0208 3648426 (office)


Pharmacovigilance Consultant

Dawson & Co Consulting


Of Counsel


Hilary is a senior associate in the IP Regulatory team and specialises in all aspects of EU and UK law in the bio-pharmaceutical and medical devices sectors.  Hilary was previously part of the in-house legal team at Pfizer for twelve years and has also worked at Gilead Sciences. As a senior corporate counsel she supported the UK, EU and global business units, gaining excellent knowledge of the pharmaceutical industry enabling her to bring a strong business approach to her legal advice.  Her experience ranges from the early stages of a product’s development to post marketing activities and long established brands. Hilary regularly speaks at public conferences on topics such as paediatric research, HTA and market access, and orphan designation for medicines. Prior to working within the pharmaceutical industry Hilary spent two years in the legal team at the Consumers’ Association (and Which?) specialising in consumer law, general commercial matters and public affairs activities.


     LLB Law, University of Southampton
     LPC, Nottingham Law School
     Qualified 2001


Virtue Insight

Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.

Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.


Pharma Phorum

Pharmaphorum is the primary facilitator of thought leadership and innovation within pharma. We support the next generation of pharmaceutical industry leaders through producing, curating and publishing media that will help pharma embrace the challenges of being a healthcare solutions provider in the 21st century.

Our services include:

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Clocate.com is a leading international directory for worldwide conferences and exhibitions. Clocate.com is equipped with a unique and comprehensive search that helps you find easily any event in any category or location.  Each event includes detailed information, like, description, dates, location, map, prices, link to the official event's  website and more...

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Labiotech.eu is the leading digital media covering the European Biotech industry. Over 90,000 monthly visitors use it to keep an eye on the business and innovations in biotechnology. Hope you'll enjoy reading our stories!


FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa.  Management of international, multi-centre projects is our core competence.

FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance.

FarmavitaR+ is brand name of Farmavita Regulanet Ltd.  Visit https://farmavitar.com for more information.  Outsource anything you can think of!


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Sponsorship, exhibiting and advertising packages are designed to provide a solid platform to help you stand out and make an impact. Our programs allow you to achieve your marketing goals and deliver a maximum return on your investment. We have developed convenient and customizable packages to help your organization meet its objectives and reach your target market.

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Our conferences offer not only a unique combination of benefits (as listed above) to enable the sponsor/exhibitor to communicate the message but also a major opportunity that other forms of selling or media cannot provide.

Contact Us Today

Email - sponsor.uk@virtueinsight.com
Tel: +44-2036120886

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Tel: +91 44 64536444

Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.

What is the format of our conference programme?
The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.

What are the benefits of attending?

  • Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
  • Enjoy our informal networking at drinks and lunch
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  • Receive electronic versions of the conference documentation for use of reference post-event.
  • Get ideas for?training topics?that you might want to present as professional development sessions to others in your workplace.
  • Observe speakers from the perspective of seeing what works really well so you can learn new public speaking techniques and strategies that you can apply when doing your own presentations.
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  • Delegates also benefit from discounted rates onfuture event attendance

For more information or to register at the event please contact us TODAY:

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Introductory Offer (3 delegate places for the price of 2):- A huge saving of £1150 - (Limited seats left) - You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com

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Testimonials from our past Pharmacovigilance Conferences



Very nicely managed. Good Speakers & content. Cooperative and convenient venue. Nice management of time. Good opportunity for networking – Assistant Manager Pharmacovigilance, Mega Lifesciences

14th Pharmacovigilance Summit 2017 was an insightful and quite resourceful in the area of pharmacovigilance and the upcoming guidelines which is expected to come in force by 1st Jan 2018 AGM – Business Development, Clinical Trial Services

The Venue, key speakers included from big pharma companies & CROs has been perfect for the topic of panel discussion MSA, George Clinical

Very good conference to have knowledge about pharmacovigilance in briefly & also to understand the guidelines of India which is coming in 1st Jan 2018 Regulatory Affairs Executive, Ashish Lifesciences

The session was knowledge transfer/sharing and valuable too Associate Manager, IQVIA (formerly known QuintilesIMS)

Thanks Virtue Insight  Piyush Patel for providing the stupendabulous experience of 13th Pharmacovigilance Conference in Chicago (27-28 Sep). Really worth attending this platform which constituted of wonderful people of the industry around from brilliant experience and background. Very well planned and coordinated; flawless activities all 2 days long.  All the best to you and the team for events ahead. – Region Head, Business Development and Program Delivery, Turacoz Healthcare Solutions

Content very relevant. I learnt many things / got clarification on several points. – Sr. Manager PVCompliance, Gilead Sciences

Actually, I need only one word for the feed-back and testimonial: EXCELLENT.
To be a bit more specific, I would like to mention that the conference was very well organized, from preparation, communications, venue-selection, agenda, all the way to the food and networking mixer.
The selection of experts was well-mixed across the field yet focused on the subject of the conference, ensuring a lively and fruitful exchange of ideas.
The size of the conference was perfect for valuable discussions in the meeting and around it, and for highly meaningful networking.
The atmosphere of the conference was focused yet relaxed, making this at the same time a very valuable learning and networking opportunity and a pleasure to attend.
Thank you very much for bringing me to this excellent conference, it was an honour, a pleasure, and a very valuable learning and networking experience.– Director Clinical Cytometry, Biomarker Technologies, ECTR, Bristol-Myers Squibb

Good efforts, well organised, experienced speakers, current and concrete topics. Promises delivered – Pharmacovigilance Manager, Cheplapharm Arzneimittel GmbH

A lot of interesting topics – Global Compliance and Quality Director, Kantar Health

Well organised, Thank you – Senior DSA, Covance CAPS

The content of the conference is always good. Good to see speakers from regulatory authorities. Always delighted to attend your conference Medical Services, Cipla

Conference was very informative & added much knowledge about Pharmacovigilance systems, ADE, process flow of reporting, searching data & mobile networking Asst. Manager Regulatory Affairs, Emcure Pharmaceuticals

Well arranged and good interactive crowd AVP - Medical Affairs and Pharmacovigilance, Veeda Clinical Research

Yes, it is good platform to understand the current industrial practice & the thought process Assistant Manager, Clinical Research & Pharmacovigilance, Bharat Serums And Vaccines

Very good coverage of the area of PV Safety Physician, Sciformix Technologies

It was a good learning experience Team Leader, Cognizant Technology Solutions

Good platform to know about peers in the industry and for knowledge sharing Pharmacovigilance Associate, Quanticate

Over all the conference was helpful Senior Director - Clinical, Aris Global Software

This kind of conference is very important for younger generations and professionals to get mere awareness and day to day updates in markets CIO, Qtech Solutions

A commercial knowledge venture explored several areas under the topic. Very good and Professional speakers. Over all more than satisfaction Director, SYNORBS BIOSOLUTIONS

Panel discussions are very interactive as well as address real world and practical issues Head – Medical Affairs, Wockhardt

I deeply appreciate the way you have organised the 11th Pharmacovigilance 2016. I would like to congratulate the whole team of virtue Insight for successfully organizing this meet. I am delighted to have participated in the meet, I had the opportunity to interact with field experts and totally i had a wonderful experience being their. Your team work was well established and everything was in place. The way you have organised the lectures and discussion on the floor is deeply appreciated. My Best wishes to the whole team of Virtue Insights Director, SYNORBS BIOSOLUTIONS

The 9th Pharmacovigilance 2015 conference was a very thought provoking day. The content of the conference was great; experienced, talented speakers and size was enough for really good conversations. I have enjoyed the whole conference. My brain was both stretched and strained – never exhausted - Senior Manager - Regulatory Operation, Medical Affairs Wockhardt Limited

Very good platform to meet other pharmacovigilance expertise and interact with them about the advances & opportunites in pharmacovigilance. Virtue Insights is really good at coordinating and organizing - Safety Physician, Sciformix

It was very good conference. Thank you very much for offering me a speaker position. Keep up the good work and all the best for future conference - Head Pharmacovigilance, Wockhardt

End to end PV process discussion would be more helpful - Medical Writer, Parexel

It was really helpful in the terms of sharing knowledge - Drug Safety Specialist, Cipla

Very well organized and the sessions were so well placed. Got enough time for networking and well time managed - Country Safety Lead, Pfizer Limited

This conference is very useful for my work. I expect that every year Virtue Insight will organized this kind of conference - Research Scientist, Alembic Pharmaceuticals Limited

“The whole session was more lively and in particular the panel discussions” - PV Lead & Deputy QPPV, Auden Mckenzie (Pharma Division)

I liked the variety of presentations - Vice President - EU QPPV, The Medicines Company

Chairman was excellent. Speakers all delivered great talk. Great discussions, exchange and brainstorming was very useful - Associate Director, Global Drug Safety & Risk Management, Celgene Europe

Very Insightful – Speakers were very knowledgable - Manager, Results healthcare

Topics deliberated on social media were a good break from usual topics at pv conferences. A good line up of speakers - Consultant, Adamas Consulting

Well thought topics, very interactive session - Principal Consultant, Adamas Consulting India

Good informative and knowledge sharing session - Manager, Ranbaxy

A very good platform where cream of the Pharmacovigilance field of Indian pharma shared their views/opinions on involving of Pharmacovigilance trends & how to improve pv in India - Business Development Associate, Techsol Systems India Pvt Ltd

Informative session focusing on new and grey areas of Pharmacovigilance patient care being the utmost priority on minds of all the pharma company new aspect discussion and light on the grey areas had open new arena for Pharmacovigilance
thank you - Drug Safety Associate, Cipla

Well organized - focused on relevant topics - excellent choice of speaker’s food for thought - Head Pharmacovigilance, BMS India

The conference was well organized Content and quality of discussion were more informative. Thank you Virtue Insight - Head Pharmacovigilance, Wockhardt

I would truly like to appreciate the efforts and initiative of Virtue Insight in organizing this PV dedicated conference. I think its one of its kind in India, where the meeting is focused only on Pharmacovigilance. Kudos to the team for the well- organised and well –planned meeting. Its one event resulting in the confluence of PV personnel, networking and exchange of knowledge. Keep up the good work. Thanks and good luck - Head - Pharmacovigilance, Bristol-Myers Squibb

The panel discussions did truly impart knowledge - Deputy DSR, Novartis

This conference was very good for the pharmacovigilance professionals as well as business people. Organising this event and the event management was nicely done by Virtue Insight - IT Administrator, Oviya Med Safe Pvt. Ltd

The conference was interesting and was a good platform for networking. The audience and the panelists were from varying backgrounds giving an insight to various challenges being faced by the Indian industry - Manager- BD, ELC Research

Virtue Insight has established a niche for iteslf in the world of pharmacovigilance events held in India. The progressively increasing attendance from all stakeholders of Drug safety serves as a testimony to this - MD & CEO, Oviya Med Safe Pvt. Ltd

Good insight into Indian Pharmacovigilance scenario. This should happen regularly to keep the concerned updated - Team Manager, Cognizant Technical Solutions

The conference here was a good platform for discussing pharmacovigilance challenges in India and knowledge sharing with respect to pharmacovigilance - Officer Global PV, Sun Magma

Conference on pharmacovigilance was very specific to the subject and was managed well in terms of sessions held throughout the day - Associate Director, PV Delivery, Sciformix

It was indeed a rich learning experience. Hope it will continue in the future - Gayathri Subramani, Pharmacovigilance Associate, Oviya Med Safe The overall conference was informative. 3rd Annual Conference has actually started addressing the practical, day to day issues coming in the way of industrial PV solutions are disscussed - Regulatory Affeirs, Inventia Healthcare

Very nice conference - Executive - Medical Affairs, Johnson & Johnson

A well-organized conference that provides value for money not only the session, but the networker opportunities provides were very useful for building companies like Oviya Med Safe - Founder & CEO, Oviya Med Safe

The conference was very informative - Sr. CRA, Clininvent Research Pvt . Ltd

Very well organised Conference with speakers having appropriate expertise and adequate enthusiasm to dissipate acquired knowledge - President R&D, FDC Ltd

The Conference was a good platform for getting views about Pharmacovigilance practices across pharma companies - Asst. Manager - Medical Affairs, Wockhardt

Very enlightening subject specific. Good mix of delegates from industry and academics - Senior Executive - Clinical Research, Wockhardt

Worth Attending ! Loved the experience! - MSC Clinical Research, ICRI - Ahmedabad

Very Informative sessions - CSO, Boehringer Ingelheim

The Panel Discussion were highly informative and Interesting. It was great learning experience & foundation for organisation who are in the process of setting up their PV systems. We look forward for more such support - Senior Manager - Regulatory Affairs, Inventia Health Care

"The conference was indeed a great experience.Both the presentations and the panel discussions/interactive sessions were very enlightening.I would surely like to attend the  May clinical trial conference. I congratulate Virtue Insight for organizing a very useful and interesting Conference." - Medical Department, Elder Pharmaceuticals

“PV 2010 was an opportunity to identify future clients as well as competitors along with an excellent learning platform” - Pharmaceutical Professional, Ecronacunova

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