8th Pharmacovigilance 2015
Offering our customers the knowledge and connections for a profitable business
  • Michael Richardson

    Michael Richardson Bristol Myers Squibb

  • Kathy Williams

    Kathy Williams AstraZeneca

  • William Gregory

    William Gregory Pfizer (USA)

  • Michael Bean

    Michael Bean Johnson & Johnson

  • Phillip Eichorn

    Phillip Eichorn Pfizer

  • Catherine Akers

    Catherine Akers Amgen

  • Sophie Molle

    Sophie Molle World Customs Organization

  • Eszter Teleki

    Eszter Teleki Bristol-Myers Squibb

  • Akshaya Nath

    Akshaya Nath Lambda Therapeutic Research

  • John Parkinson

    John Parkinson Healthcare Data (Former Director CPRD, MHRA)

  • Sumit Munjal

    Sumit Munjal Takeda Pharmaceuticals

  • Deborah Layton

    Deborah Layton Drug Safety Research Unit (DSRU)

  • Brian Edwards

    Brian Edwards NDA

  • David Jefferys

    David Jefferys Eisai Pharmaceuticals

  • Barbara Dawson

    Barbara Dawson The Medicines Company

  • Steinar Madsen

    Steinar Madsen Norweigen Medicines Agency

  • Nawab Qizilbash

    Nawab Qizilbash OXON Epidemiology

  • Veronique Basch

    Veronique Basch UBC

  • James Sawyer

    James Sawyer Prism Ideas

  • Peter-Christoph Schulz

    Peter-Christoph Schulz PCS Pharmacovigilance

  • Veronica Fjellstrom

    Veronica Fjellstrom Bluefish Pharmaceuticals

  • Leo Ayerakwa

    Leo Ayerakwa European Regulatory Solutions

  • David Chen

    David Chen Hydrogen Group

24th & 25th February 2015, Marriott Marble Arch Hotel, London, UK

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

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  • Conference Info
  • Day One
  • Day Two
  • Speakers
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  • Delegates
  • Pricing
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  • Testimonial
  • Presentations
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3 for 2 Offer (3 delegate places for the price of 2):- A huge saving of £ 1100 - (Limited seats left) - You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com

Standard Registration:- Conference Delegate Pass (£ 1100 + VAT (20%) per delegate) – You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com

Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to – TEL: +44 2036120886. Email – sponsor.uk@virtueinsight.com


The emerging markets are rapidly evolving to compete with the standards set by the developed world. Many life sciences companies are now focusing strongly on drug safety management and pharmacovigilance. Demand from emerging markets is opening up various opportunities across multiple sectors. Life sciences companies have several compelling reasons to build a presence in emerging markets. By 2020, the size of the global pharmaceutical market is anticipated to grow to USD 1.3 trillion, with the E7 countries -- Brazil, China, India, Indonesia, Mexico, Russia and Turkey. The rapid induction in the market throws up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. All medicines (pharmaceuticals and vaccines) have side effects. Some of these side effects are known, while many are still unknown even though that medicine has been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of medicines in order to determine any new information available in relation to their safety profile. A good pharmacovigilance will easily identify the risk factors in the shortest time so that the harmful effects can be avoided or minimized.

8th Annual Pharmacovigilance 2015 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 academic 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 organisations' 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 8th Pharmacovigilance 2015.  I wish and pray that all our efforts will be beneficial to our industries and to our country at large


  • Update yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practice in PV
  • Developing Pharmacovigilance into high quality management system and its components
  • Audit and Inspection: Realistic steps for a fruitful consequence
  • EMA PSMF - Assuring compliance and provide standardization
  • Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
  • Exploiting the pharmacy automations and technologies for enhancement of medication safety
  • Developments in Pharmacovigilance, drug safety & risk management to ensure safer drugs to market
  • Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions
  • Determining the steps and strategies for enhancing quality in healthcare
  • Emerging signal detection data gathering successful tools to highlight emerging risks
  • IT solutions for Pharmacovigilance – Learn & Explore
  • Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
  • GVP Module V and XVI – explaining authority expectations and avoid speculation and differing interpretation of the current guidelines
  • Review the use of (PSURs) post-authorisation for safety signals
  • ICH-R3 standards - Determining where future challenges could arise
  • The developing regulatory framework in advanced and developing markets
  • Accelerating new medicine introduction in developing world & overcoming challenges
  • Explaining how to use the data sources and observational research for effective safety analysis
  • Be part of a major networking opportunity 


  • 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 Marketin


8th Pharmacovigilance 2015 – “Uniting “Ensuring safer drugs to market by analyzing 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

Nawab Qizilbash, Head & Honorary Senior Lecturer in Pharmacoepidemiology, OXON Epidemiology


09:40 – Risk Minimisation

  • Expectations from regulators
  • Development of  additional risk minimisation measures
  • Evaluation of additional risk minimisation measures

Nawab Qizilbash, Head & Honorary Senior Lecturer in Pharmacoepidemiology, OXON Epidemiology

10:20 – EMA PSMF - Assuring compliance and provide standardization

  • Presenting inspection findings and revealing
  • What does the authorities expect to see to ensure positive reviews upon inspection
  • Maintaining up to date master files and to comply with GVP module II guidelines
  • Providing advice and feedback on the creation and number of KPIs to determine the ideal strategy for your business
  • Exchanging PSMF information with license partners to ensure full compliance
  • Receiving external audits from license partners to decipher if this will be applicable with the implantation of PSMF

Veronica Fjellström, Deputy QPPV, Bluefish Pharmaceuticals

11:00 – Morning Coffee/Tea & Discussion

11:20 – PV @ Lambda – an integrated circuit

  • Lambda operations
  • PV – Integration of ops
  • Handling ARs
  • People – the asset base
  • PVnet – the circuit

Akshaya Nath, Senior Vice President, Global Operations & Business Development, Lambda Therapeutic Research


12:00 – Keynote Panel Discussion: Challenges and Opportunities in PV lifecycle management

  • Staying ahead in the race - Update on PV in EU, USA & RoW - Current trends for PV, and new and future guidelines
  • Case studies: what can we learn from successful experiences from RoW?
  • Identifying the key opportunities for biopharmaceutical outsourcing in the area of PV
  • Litigation, risk and latest developments and trends within PV technology
  • Guideline on GVP in EU
  • Overview of the key elements for Post-authorisation Safety Studies (PASS) and Post-authorisation Efficacy Studies (PAES)
  • Why does pharmacovigilance sometimes fail and where could fault lie?


Nawab Qizilbash, Head & Honorary Senior Lecturer in Pharmacoepidemiology, OXON Epidemiology


Michael Richardson, VP International & QPPV EU GPV&E, Bristol Myers Squibb

Steinar Madsen, Medical Director, Norweigen Medicines Agency

Brian Edwards, Principal Consultant, Pharmacovigilance & Drug Safety, NDA

12:40 Networking luncheon

14:00 – Benchmarking Drug Safety and Pharmacovigilance

  • How to choose among the available drug safety vendors
  • Discover how to improve supplier-client relationship
  • How to optimize and strengthen your drug safety team?
  • Importance of improving your communication with the FDA
  • Identify the most important challenges towards improved safety and monitoring of drugs.
  • Aligning the team and assigning responsibilities for investigational and post-market products

Veronique Basch, Executive Director, Global Pharmacovigilance, UBC


14:40 Emerging signal detection data gathering successful tools to highlight emerging risks

  • Using pharmacovigilance databases to facilitate the detection of adverse events and the generation of safety signals
  • Leveraging external data sources to supplement the quantity of data available in company-owned databases
  • Examining information provided in Individual Case Safety Reports (ICSRs) to determine whether a signal should be investigated or not
  • Examining aggregate reports periodically to identify potential signals that were not detected from individual data

Pipasha Biswas, Director, Symogen

15:20 – Afternoon Tea/Coffee

15:40 – Challenges in designing PASS in the era of guidelines

  • Fulfilling the need for innovation
  • Understanding the local health services in practice
  • Study design considerations when there is no comparator
  • Real-life case examples

Deborah Layton, Principal Research Fellow, Drug Safety Research Unit (DSRU)

16:20 – IT solutions for Pharmacovigilance – Learn & Explore

  • Innovative software to analyse risk data and target inspection activity
  • Risk-based inspections regime which ensures compliance with statutory obligations relating to medicines
  • Technical Challenges – What does the QPPV need to know?
  • Outsourcing in the Modern PV World – Perspectives from both sides

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

Nawab Qizilbash, Head & Honorary Senior Lecturer in Pharmacoepidemiology, OXON Epidemiology

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

David Chen, Consultant - Regulatory, Quality & Pharmacovigilance, Hydrogen Group


09:40 – Morning Keynote Address 1 – Risk Management Plans up-to-date

  • What are the key challenges that we now face with RMPs?
  • What’s an important risk? What are regulatory expectations? How do we deal with differing
  • interpretation of the current guidelines?
  • Risk management throughout a product’s lifecycle. How do we assess, document and communicate a changing/evolving Benefit-Risk balance over time?
  • Risk management throughout a safety signal’s lifecycle: from safety signal to risk/benefit management. Can a risk ever be ‘retired’?
  • Transparency: how to achieve patient/prescriber communication to guarantee maximum patient safety

Phillip Eichorn, Senior Director (Worldwide Safety and Regulatory), Pfizer

10:20 – Morning Keynote Address 2 – Safety surveillance and risk management lifecycle

  • Signal detection and – management
  • Safety surveillance integrating multiple data sources
  • Assessment of risks and important risks
  • Risk management and risk minimization
  • Risk minimization effectiveness measurement

Peter-Christoph Schulz, Director, PCS Pharmacovigilance

11:00 – Morning Coffee/Tea & Discussion


11:20 – Morning Keynote Panel Discussion - Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients

  • Four-way relationship between sponsors, sites, CROs & patients - Realistic expectations, clear communications, shared understandings, practical policies, and efficient problem resolution
  • How to source the right partners, sponsor, vendor partnerships and avoid mistakes in selecting an outsourcing partner to conduct clinical trials
  • Patient-centric approach to clinical trials
  • How will CRO's analyse the current opportunities to invest in early stages of drug discovery or biotechnology start-ups?
  • In what way can the realistic expectations, clear communications, shared understandings, practical policies, and efficient problem resolution methods be developed between sponsors, sites and CROs
  • The current perspectives on the future of outsourcing in Asia
  • Advantages of a collaborative clinical trial alliance for greater efficiency and cost reduction


Eszter Teleki, Group Director - Regulatory Procedure Management & Operation & Regulatory Policy - GRS-Europe, Bristol-Myers Squibb


William Gregory, Director - Safety & Risk Management, Pfizer (USA)

Sumit Munjal, Global Director, Pharmacovigilance & EU Region Medical Advisor - Lead Oncology Portfolio, Takeda Pharmaceuticals

Barbara Dawson, Vice President - EU QPPV, The Medicines Company

12:00– Data for European Pharmacovigilance and Pharmaco-epi- what’s needed?

  • Hypothesis generation, strengthening and testing, the right data for the right task
  • What are the limitations of the data - phenotype, genotype, and healthcare system?
  • Are there geographic boundaries?
  • So what data is there for European drug and device benefit risk research?

John Parkinson, Consultant Expert, Healthcare Data (Former Director CPRD, MHRA)

12:40 - Networking luncheon


14:00 – PV Audit & inspections - preparation, implementation and lessons to be learnt

  • What are relevant interactions during the PV inspections
  • Audits to develop, establish, promote and align with international standards
  • Identifying best criteria for PV inspections to maintain constant vigilance
  • Standardizing PV auditing procedures
  • Integrating PV into clinical practice, through training and education

Michael Bean, Senior Director, Regulatory Compliance R&D at Janssen, Johnson & Johnson

14:40 - Launch of the WCO IPM mobile application featuring new developments to provide the field officers with relevant weapons to better fight against counterfeiting

Sophie Molle, IPM Private Sector – Senior Manager, World Customs Organization

15:20 – Afternoon Tea/Coffee

15:40 – PV for Biologics – New Legislation, New Requirements

  • High level overview of why biologics and their specific characteristics which give rise to unique challenges for PV
  • Importance of accurate track and trace
  • Requirements of the European PV legislation and what it means for stakeholders

Catherine Akers, Senior Regulatory Affairs Manager – EU Policy, Amgen


16:20 – Panel Discussion: The developing regulatory framework in advanced and developing markets – for Today & Tomorrow

  • Keep abreast with the changing International regulations of PV
  • ICH-R3 standards - Determining where future challenges could arise
  • A brief recap of recent regulatory developments. Ensuring you comply with market requirements
  • Regulatory updates and GVP modules overview
  • Current PV practices in the EU & US
  • PRAC: Initial Assessment – regulatory & industry perspective
  • Regulatory considerations towards staffing and recruitments


Leo Ayerakwa, Regulatory Affairs Consultant, European Regulatory Solutions


Kathy Williams, Lead Pharmacovigilance & Regulatory Excellence, GRAPSQA, AstraZeneca

David Jefferys, Sr. VP Regulatory, Eisai Pharmaceuticals

David Chen, Consultant - Regulatory, Quality & Pharmacovigilance, Hydrogen Group

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

David Chen, Consultant - Regulatory, Quality & Pharmacovigilance, Hydrogen Group

Michael Richardson

VP International & QPPV EU GPV&E

Bristol Myers Squibb

Michael Richardson has over 25 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.

Kathy Williams

Lead Pharmacovigilance & Regulatory Excellence, GRAPSQA


Kathy has a long experience of working in the Pharmaceutical industry, starting her career at the research laboratory bench. Kathy moved away from research and into Regulatory Affairs at AstraZeneca 18 years ago and has taken several lead Regulatory roles, building specialist knowledge in the Latin America/Caribbean and European regions. In her current role, Kathy focuses on new and evolving Pharmacovigilance legislation globally and the impact that has on Regulatory submissions and internal working processes supporting the Pharmacovigilance System. Kathy is based at AstraZeneca in Macclesfield, UK.

William Gregory

Director - Safety & Risk Management

Pfizer (USA)

Dr Gregory is director of safety and risk management at Pfizer; his formal training is in infectious diseases and molecular mechanisms of pathogenesis. He has more than 15 years of experience directing successful product development programmes and participates in global consensus forums, such as ICH and CIOMS. He also serves on the faculty of the EU IMI Eu2P programme in pharmacovigilance and pharmacoepidemiology and EMA's Excellence in Pharmacovigilance training programme, among others. He has authored or co-authored more than 40 scientific publications, including chapters in Mann's Pharmacovigilance and Drug Safety and Pharmacovigilance (Mandarin). Prior to joining Pfizer, Dr Gregory was a pathology professor and consultant to the US government.

Michael Bean

Senior Director, Regulatory Compliance R&D at Janssen

Johnson & Johnson

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.

Phillip Eichorn

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.

Catherine Akers

Senior Regulatory Affairs Manager EU Policy


Catherine Akers has worked at Amgen for more than 10 years working in Regulatory Affairs, most recently as a Senior Manager in the Policy Group. Whilst working with Amgen, Catherine has worked in the areas of CMC in addition to clinical trials and  post marketing activities.This has allowed a thorough insight into the unique ways that biologics are developed and their key features. Catherine has a special interest in pharmacovigilance requirements for biologics including biosimilars, as called out in the recent update to the EU Pharmacovigilance legislation, together with the need to ensure traceability of biologics from prescription to end-user, in addition to other issues which effect biologics and biosimilars. She is also involved with the European Trade associations at both EBE and EuropaBio.

Sophie Molle

IPM Private Sector Senior Manager

World Customs Organization

Since 2010 Sophie Molle is IPM Senior Project Manager for the Private Sector at the World Customs Organization based in Brussels.

The World Customs Organization is the only intergovernmental organization exclusively focused on customs issues and is composed of 179 Members.

Sophie is responsible for the promotion of the IPM tool amongst the private sector with her global team. She is also involved in the development of the IPM Connected programme, which mainly focuses on collaborating with authentication and track/ trace technologies.

Prior to the WCO, Sophie was working in the meeting industry in France.

Eszter Teleki

Group Director - Regulatory Procedure Management & Operation & Regulatory Policy - GRS-Europe

Bristol-Myers Squibb

DR ESZTER TELEKI, Group Director, Regulatory Procedural Management and Operation & Policy, Europe-at Bristol-Myers Squibb, member of the EFPIA ERLC group

Dr. Teleki, a medical doctor by training, is a very experienced regulatory professional with 20 years of wide pharmaceutical and 18 years of diverse regulatory experience.

Dr Teleki  currently is managing the European operational activities at Bristol-Myers Squibb, including the European Regulatory Procedure Management Team, which is responsible for  the operational, procedural management for  Europe  and also the business operation, HA engagement and regulatory policy matters.

In the past, she held different positions, including regulatory country head and European Strategy Liaison and  has been member of several Industry committees mainly at PhRMA and EFPIA, including EU Accession Task Force and the Regulatory Affairs Group.

Currently  she is member of EFPIA's ERLC and its CP&SA subgroup and co-lead the  PRAC Task Force.

Akshaya Nath

Senior Vice President, Global Operations & Business Development

Lambda Therapeutic Research

John Parkinson

Consultant Expert

Healthcare Data (Former Director CPRD, MHRA)

Sumit Munjal

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

Takeda Pharmaceuticals

Dr Sumit Munjal is a qualified physician from India with clinical experience in the field of General Medicine & Neurosciences working in the NHS, UK. He completed his research Masters’ degree in Epidemiology from London School of Hygiene & Tropical Medicine (LSHTM) and gained Fellowship with the Royal Society for Public Health.

Subsequently, he worked in the field of pharmacoepidemiology at the Drug Safety Research Unit (DSRU), Southampton and as a Medical Assessor at the MHRA, Dept of Health, UK where he was involved in the decision-making of some important EU and international regulatory drug safety issues.

He has worked with pharmaceutical companies such as Johnson & Johnson, Millennium Pharmaceuticals Inc, Nycomed and Takeda Pharmaceuticals in the area of Oncology unmet medical need and more established products. He is currently working as a Medical Director Lead, heading up Mature products portfolio in Global Pharmacovigilance with Takeda and is based in Central London, UK.

He also involved in academic assignments with the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom

Deborah Layton

Principal Research Fellow

Drug Safety Research Unit (DSRU)

Deborah Layton graduated from Aston University, Birmingham in 1989 with a BSc in Pharmacy, and registered with the Royal Pharmaceutical Society of Great Britain in 1990. She has extensive experience og research within healthcare as well as several postgraduate qualifications in pharmacy, pharmacoepidemiology and statistics with applications in medicine. At the DSRU, in her present role she consults on observational study designs for risk management plans and methodological development. She is highly published, provides peer review of manuscripts submitted to a number of scientific journals and is on the Editorial Board of the journal Pharmacoepidemiology and Drug Safety. She is a member of the education committee and abstract acceptance committee for international conferences held by the International Society for Pharmacoepidemiology (ISPE) and also a member of the International Society of Pharmacovigilance (ISOP). As Honorary Senior Lecturer at the University of Portsmouth (UoP), she gives lectures on pharmacovigilance to pharmacy students. She also presents at national and international conferences. She is also Academic contact for the MSc Pharmacovigilance which is a collaborative programme between the DSRU and UoP.

Brian Edwards

Principal Consultant, Pharmacovigilance & Drug Safety


1980 - 1994 Qualified University of London, Guy's Hospital Medical School followed by hospital medicine and clinical research: general medicine, 6 years in renal medicine, principal investigator in London, Birmingham, and Manchester attached to Renal Unit Royal Infirmary.

1994 -1999 Senior Medical Assessor UK Medicines Control Agency – Senior Medical Assessor in Pharmacovigilance Assessment Group.

1999 - 2005 Senior Medical Director in a global CRO – Parexel Scientific and Medical Services – with responsibilities in pharmacovigilance and clinical trials.

2005 - 2007 Deputy Qualified Person for pharmacovigilance for Janssen Cilag.

Since July 2007, Dr Edwards has been a Principal Consultant in Pharmacovigilance and Drug Safety with NDA Regulatory Science Ltd based in Leatherhead, Surrey, UK. In addition, he chairs the QA panel overseeing the training of UK pharmaceutical physicians on behalf of the UK Faculty of Pharmaceutical Medicine and he is Director of ISoP Secretariat Ltd, is on the ISoP Executive Committee and is Treasurer as of November 2012. He is also Vice President in the Alliance Clinical Research Excellence and Safety (ACRES). He is co-chair of PharmaHUF in the UK & Ireland.

David Jefferys

Sr. VP Regulatory

Eisai Pharmaceuticals

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 Liaison Committee and sits on the scientific policy committee (SRMPC).

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.

Barbara Dawson

Vice President - EU QPPV

The Medicines Company

Barbara Dawson joined the Medicines Company in October 2012 as Vice President Qualified Person for Pharmacovigilance (QPPV) Europe and Pharmacovigilance Compliance.

Barbara has over 25 years of experience in the drug industry mainly in Pharmacovigilance/Drug Safety. She has experience in working for small, medium and large pharmaceutical/Biopharmaceutical companies, global and local, medicines and devices and has been involved in and directly responsible for a number of PV setup, re-engineering and outsourcing projects.  She also has experience working in the CRO industry. Positions held include Qualified Person for Pharmacovigilance, Global Head of Pharmacovigilance, Regional Head of Pharmacovigilance and Head of Case Processing.

Barbara has a Bachelor of Science (hons) in Pharmacy from the University of Natal in Durban, South Africa. She is a professional registered pharmacist.

Steinar Madsen

Medical Director

Norweigen Medicines Agency

Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency, where he has almost 20 years of experience. Among others, his tasks at the Agency are drug information including safe use of drugs and pharmacovigilance. He is a specialist in internal medicine and cardiology and works part time as a consultant.

Nawab Qizilbash

Head & Honorary Senior Lecturer in Pharmacoepidemiology

OXON Epidemiology

Nawab Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) is Head of OXON Epidemiology, a preferred CRO provider for EU risk management studies for several big pharma companies, and Honorary Senior Lecturer in Epidemiology, London School of Hygiene and Tropical Medicine and Honorary Consultant Geriatrician, Madrid

Nawab was Director of Clinical Epidemiology, GSK (1997-2005) and provided advice for risk management and signal detection, during a secondment as a safety physician. He trained under and worked with Professor Sir Richard Peto FRS (eminent medical statistician and epidemiologist) and was Honorary Consultant Physician in Oxford (1997-2000), and St. Mary's Hospital, London (2005-2006).

At the EMA, Nawab chairs the ENCePP data integration guidance group, sits on the ENCePP Steering Group and is an ENCePP ‘EMA expert’.

He is co-author of x5 Lancet, x1 JAMA and x3 BMJs, with a publication currently in press in Lancet Diabetes & Endocrinology, as first author, together with Professors Stuart Pocock (eminent medical statistician) and Stephen Evans (PRAC member).
He teaches annually with leading regulators (PRAC and national regulatory agency) and European pharmacoepidemiologists on PASS and, specifically, risk minimisation studies.

Veronique Basch

Executive Director, Global Pharmacovigilance


Veronique Basch, PharmD, serves as the executive director of Global Pharmacovigilance.  In this role, she manages the development, implementation, and execution of UBC’s safety strategy, providing direction, oversight, and management of its global Pharmacovigilance team, located in Europe and the US.

Veronique joined HPM Healthcare & Project Management (Geneva) SA in September 2004 as head of Drug Safety where she developed the Drug Safety department activities. HPM was acquired by UBC in May 2009. Since then, she has managed the Geneva office, and in early 2011, she took over as the global pharmacovigilance practice lead. Véronique first gained international research experience in California and later at the University Hospital of Zürich. She then embarked on a career in drug safety at Novartis: first at Novartis Ophthalmics as a Medical Safety Expert and then at Novartis Pharma as a team leader in the Global Safety Operations Group.

Veronique holds a PharmD from the University Louis Pasteur in Strasbourg, France and later graduated from the University of Basel as a University Professional in pharmaceutical medicine.

James Sawyer


Prism Ideas

Dr James Sawyer is the CEO of Prism Ideas, a drug development and scientific communications consultancy with offices in the UK and Switzerland. He is also co-owner of BS Orphan a UK based SME supporting access to medicines for rare diseases and CEO of Unicorn Pharma Services which provides pharmacovigilance solutions to Pharma using artificial intelligence techniques.

James trained in internal medicine and anaesthetics prior to joining the pharmaceutical industry in the early 1990’s. He held national and global roles spanning clinical research, health-outcomes and health-economics, drug safety, medical affairs and marketing at three major Pharma companies, Sanofi, AstraZeneca and Roche prior to founding Prism Ideas in 2001. In 2010 Prism was awarded the Queen’s Award for Enterprise.

James has published widely on a variety of topics, including migraine, bone metabolism, asthma, virology, pharmacokinetics and personalised medicine. Given his background as a physician James recognises the demands of patients and healthcare providers as the ultimate end-users. He has particular expertise in the process of matching product attributes with market needs and has consulted on projects for more than sixty companies spanning many therapeutic areas across Pharma, devices and diagnostics.

Peter-Christoph Schulz


PCS Pharmacovigilance

Dr. Peter Schulz is the founder and director of PCS Pharmacovigilance LTD. A certified internist with 20 years of experience in Pharmacovigilance, Peter provides services to leading clients in the industry for safety surveillance, risk management, safety operations, systems and business automation. Previously Peter held Pharmacovigilance leadership positions at Sanofi, Roche, Amgen, Bayer and a start-up company ii4sm. Prior to joining the pharmaceutical industry Peter practiced as a physician in Germany and the US for 11 years. He received his medical degree from the University in Cologne Germany.

Veronica Fjellstrom

Deputy QPPV

Bluefish Pharmaceuticals

Veronica Fjellstrom has a Degree of Master of Medical Science from Uppsala University, Sweden. She is currently employed as a deputy EU‑QPPV at the generic pharmaceutical company, Bluefish Pharmaceuticals.

Veronica previous employment includes a position as a Head of Pharmacovigilance at a Clinical Research Organisation where she was responsible for the pre‑ and post-authorisation pharmacovigilance activities. During that period, she was also appointed deputy EU-QPPV for two pharmaceutical companies. She has mostly worked with small/medium-size pharmaceutical companies. During her years in the consultancy business she has gained valuable knowledge of the PV system set-up in various companies and she has valuable insights from audits and inspections by national competent authority.

Leo Ayerakwa

Regulatory Affairs Consultant

European Regulatory Solutions

A drug development professional with more than 18 years R & D and project management experience gained from both biotech and CRO environment and currently working in regulatory affairs as a Consultant at ERS Ltd. Strong background in the disciplines of toxicology and pharmacology in support of the clinical development of medicinal products across a number of therapeutic areas, working with multi-disciplinary teams, including drug discovery, development, regulatory affairs, licensing and commercialisation of small molecules, biological and plant-based medicinal products to international regulatory standards. Contributed significantly to securing an approval for a ‘first-in-class’ medicinal product for the treatment of the symptoms of multiple sclerosis in Europe. Has experience in the writing and reviews of the non-clinical sections of regulatory documents, including IBs, CTAs, MAA, IND and NDA. Contributed to the pharmacovigilance function during clinical trials and post-marketing activities from strategic and regulatory perspectives through safety surveillance activities and input into RMPs, PSURs and ASRs from a non-clinical angle.

David Chen

Consultant - Regulatory, Quality & Pharmacovigilance

Hydrogen Group

David Chen is currently a consultant at Hydrogen Group and specialises in the recruitment of professionals within the fields of regulatory affairs, quality and pharmacovigilance across Europe. Graduating from Queen Mary University of London, David started his career as a researcher in regulatory affairs recruitment. Identifying market trends for European pharmaceutical companies, David also established strong relationships with regulatory affairs consultants. Using his expertise, David advises new and existing clients on interim hiring solutions to help them achieve their targets within budget and in line with ever changing market trends.


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.



Lambda Therapeutic Research is a leading full service CRO in the Clinical research domain. Headquartered in Ahmedabad (India), its global footprint encompasses strategically located offices in Mumbai (India), Poland (Europe), London (UK), USA and Canada (North America)

Since its inception in 1999, Lambda has grown both organically and inorganically and has gone on to establish a truly global presence. Its prime locations world-wide ensure ground level support in addition to easy access to a competent blend of human expertise and state-of-the-art infrastructure in the most efficient yet cost effective way. Lambda has BA/BE and Phase 1 facilities in India, Poland and Canada helmed by dedicated and experienced teams. It has recently commissioned Bio Analytical and Clinical Laboratory facilities and established a Business Development office in London (UK).

Lambda’s global infrastructure comprises of an impressive tally of 600+ clinical beds dedicated to Phase I clinical studies and bioequivalence studies. It has conducted more than 4800 Phase l, bioavailability / bioequivalence and/or drug-interaction studies of over 300 different chemical entities. Lambda’s database of adult male and female volunteers now exceeds 100,000 on a global level.

Lambda has extensive experience of conducting clinical studies in subjects of diverse sub groups, such as healthy and post menopausal female populations in addition to healthy male subject populations. It has conducted studies for its clients, for several regulatory agencies including ANVISA-Brazil, EMEA (Germany, Netherlands, France and other EU member state), UK-MHRA, TGA-Australia, AGES, TPS-Canada, USFDA and WHO. Since its inception, Lambda’s world-class facilities have consistently and successfully passed regulatory inspections by regulatory agencies such as DCGI, USFDA, ANVISA-Brazil, MHRA, Health Canada, AFSSAPS, Turkish-MoH and WHO.


ADAMAS Consulting

Do you require assistance with your GVP auditing requirements?

Have you had a recent audit or inspection finding against a particular GVP process?

At ADAMAS, we place significant emphasis on adding value to the GVP service we provide to our clients. In response to industry trends and our client needs, we are continuously developing our service offerings to ensure we remain at the leading edge of GVP consultancy services worldwide. We believe that from concept to delivery, ADAMAS is uniquely placed to ensure our clients GVP compliance activities are at the forefront of industry best practice.

In 2013/2014 alone, ADAMAS conducted GVP audits in over forty countries, successfully managing global affiliate, business partner and service provider audit programmes for several pharmaceutical organisations. Our in-house GVP consultancy team has been carefully developed, based on the principle of genuine Pharmacovigilance experience, and includes former Industry and Competent Authority professionals. This level of experience ensures that we not only possess a deep understanding of the applicable regulatory requirements, but we can also deliver first-hand experience on how these requirements are applied pragmatically in industry today.

In addition to our GVP systems audit service, we also offer a unique tailored GVP process audit service, representing an opportunity for our clients to focus their compliance activities on the systems and processes where they are most needed.

At ADAMAS, we have successfully assisted organisations in preparing for their Regulatory Authority inspections. Our GVP team possesses the necessary skills and experience to guide and advise organisations through the inspection preparation, conduct and follow-up stages according to their needs.


Byte Mindz

We the ByteMindz an emerging company incorporated with an aim of providing business solutions across Web Designing, Web Application Development, Software Development and Multimedia Services inclusive of various value-added services. We work on a diverse product line of services which are developed compatible for various frameworks, providing a complete project design and development using our high standard technical team.

We believe not only to produce exceptional in-house application we focus also on enhancing the commercial values for the customer end user applications. We extend our power of imagination across various verticals of IT services making the customer highly satisfied by providing an individual attention to each and every customer irrespective of the high, medium & large scale of organization.

Our Value Added service includes the service apart from our core standard service, we give a valuable testing unit and a complete support from our back end .We would like to hear from the customer periodically and we monitor our growth based on the customer quotes & comments and work hard on fixing those reported problems and include the fixes in our library based on the system designs and code compatible requirements. For more information log on to www.bytemindz.com



Our role at Zigzag is to navigate the complex route to fulfil your quality targets. Our experienced team provides a full range of Quality Assurance (QA) services. With a completely flexible approach, we provide you with the right resource, wherever and whenever you need it.


We provide a complete range of QA services – one of our particular strengths is Pharmacovigilance. We recognise that each of our clients has individual needs. With our tailor-made services, we have a broad range of expertise to meet your requirements. So much so, it would be difficult to list everything we do. So here is a brief snapshot of our main services across all GxPs including Pharmacovigilance.

  • Auditing, including management of audit programmes
  • Developing PV systems for drug development and marketed products
  • Training
  • Inspection readiness and post-inspection support
  • Gap analysis
  • Quality management system development
  • Standard operating procedure writing and review
  • Corrective action and preventative action management
  • In-house support



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...

If you search for a conference or exhibition in areas such as Industry and manufacturing, Health and medicine, Technology and IT, Business and finance, sciences, education, services (banking, insurance, tourism, Hospitality and more), government, environment, life style and arts, you'll find it in Clocate.com

Reports and Reports

ReportsandReports comprises of an online library of 50,000 reports, in-depth market research studies of over 5000 micro markets, and 25 industry specific websites.

Our client list boasts of almost all well-known publishers of such reports across the globe. We, as a third party reseller of market research reports employ number of marketing tools such as press releases, email-marketing and effective search engine optimization technique to drive revenues for our clients.


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:

  • Publication of interesting new written, audio and video content addressing critical pharma issues from around the world.
  • Showcasing key service providers who can work with pharma executives to forge the business models of the future.
  • Curation of global news, industry events and job opportunities within pharma.
  • Production of written, audio and video content for publication on pharmaphorum or client channels.
  • Advice and support on the use of social media within pharma to effectively connect companies, improve PR and share innovation.

Markets and Markets

MarketsandMarkets is a full service and consulting firm that produces strategically analyzed full length reports track more than 10 industries. M&M plans to launch industry-wise and country wise market tracker for all the verticals tracked. This intelligence database comprising of about 60000 reports a year will form one of the world's largest intelligence resources worldwide. MarketsandMarkets has effectively used technology to automate management of large and complex data for forecasts. MarketsandMarkets aspires to help its client to achieve sustainable growth by providing incisive business insights into their respective business partners. Our 200 global strategic accounts with topline revenues in excess of USD 1 Billion annually. Delivered syndicated research studies to top publishers globally on a subcontracting model. The major industries that we cover in our market intelligence deliverables are Pharma & Biotech, Telecom & IT, Healthcare & Life sciences, Chemical & Advanced Material, Electronics & Semiconductors and Foods & Beverages.

Going to meet

Partnering with Virtue Insight means more than making the right contacts. It means being an insider. It means being connected to the right people with the right level of influence, and it means you are allied with a globally respected organization and leaders in the industry.?

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.

Why Sponsor / Exhibit:

PROFIT: To Maximize
MARKET SHARE: Defending and Increasing Market Share
COMPETITION: To attach and defend against competition


  • Generating sales leads
  • Build brand image
  • Maintaining customer relations
  • Consolidating business relationships
  • Accessing new and emerging markets
  • Obtaining technical knowledge
  • Leverages the events extensive marketing campaign to add value to your organisations marketing strategy and budget leading up to the event
  • Live product demonstration to test market responses
  • Facilitating quick market penetration
  • Reach important targeted commercial prospects face to face in a social, relaxed environment. The ideal platform to build strong business friendships Strengthen your market position

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

Email - sponsor@virtueinsight.com
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
  • Meet the leading solution providers in the market to forge partnerships and discover solutions
  • 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.
  • Learn what not to do in presentations if you end up sitting through any sessions that fail to be engaging or informative.
  • Delegates also benefit from discounted rates onfuture event attendance

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

Contact Us Today

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

Email - delegate@virtueinsight.com
Tel: +91 44 64536444

Coming Soon...

“The whole session was more lively and in particular the panel discussions”

Vijayakumar Bathala
PV Lead & Deputy QPPV, Auden Mckenzie (Pharma Division)

I liked the variety of presentations

Barbara Dawson
Vice President - EU QPPV, The Medicines Company

Chairman was excellent. Speakers all delivered great talk. Great discussions, exchange and brainstorming was very useful

Marie-Pierre Cursan
Associate Director, Global Drug Safety & Risk Management, Celgene Europe

Very Insightful – Speakers were very knowledgable

Brigitte de Lima
Manager, Results healthcare
DOWNLOAD Brian Edwards, NDA
DOWNLOAD Akshaya Nath, Lambda
DOWNLOAD Catherine Akers, Amgen
DOWNLOAD Deborah Layton, Drug Safety Research Unit (DSRU)
DOWNLOAD Nawab Qizilbash, OXON Epidemiology
DOWNLOAD Peter-Christoph Schulz, PCS Pharmacovigilance
DOWNLOAD Phillip Eichorn, Pfizer
DOWNLOAD Pipasha Biswas, Symogen
DOWNLOAD Sophie Molle, World Customs Organization
DOWNLOAD Veronica Fjellstrom, Bluefish Pharmaceuticals
DOWNLOAD Veronique Basch, UBC
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