4th Pharmacovigilance 2013
Offering our customers the knowledge and connections for a profitable business
  • Fiona Maini Deloitte Consulting

  • Sarah Derry Diamond PV Services

  • Saad Shakir Drug Safety Research Unit

  • Shelley Gandhi NDA Regulatory Services

  • Stephanie Jones Medicorum

  • John Talbot University of Hertfordshire

  • Robert L Bencher Myriad-RBM

  • Pipasha Biswas Symogen

  • Sandy Eisen Frontline Pharma Consulting

  • Graeme Ladds PharSafer

  • Swapu Banerjee Pope Woodhead

  • Philippe Devos PAREXEL

  • Geraldine Aubes UBC

  • Sumit Munjal Takeda Oncology Company

  • Bridget King MHRA

  • Brij Patel MHRA

  • Mustafa A.Zaman PAREXEL Consulting

  • Hans Van Bronswijk PAREXEL Consulting

  • John Parkinson MHRA

  • Irfan Ahmad AstraZeneca

  • William Gregory Pfizer

  • Julia Appelskog Merck

12th & 13th March 2013, Marriott Regents Park, London U.K

“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
  • Sponsors
  • Partners
  • Sponsorship Opportunity
  • Delegates
  • Pricing
  • Venue
  • Testimonials
  • Presentations
  • Gallery


It is estimated that the average spend on pharmacovigilance is 6% to 13% of a companies total R&D. From product development in clinical trials to post marketing surveillance, adverse drug reactions are monitored and safety signals investigated. The new legislation includes sweeping changes that leave industry with a lot of questions. If you want to file your product in Europe (MAA), what new PV regulatory processes do you need to put in place? Will the Pharmacovigilance System Master File be useful? And what is really meant by a Quality Management System?

The Conference 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.

4th Pharmacovigilance 2013 is the latest in Virtue Insight’s series of successful pharmacovigilance events. Also it can help you control your product's lifecycle, your patient's trust, and your revenue. Hence, 4th Pharmacovigilance 2013 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 4th Pharmacovigilance 2013. I wish and pray that all our efforts will be beneficial to our industries and to our country at large.


  • Exploiting the latest technologies, methodologies and introducing pharmacy automations on work practices of Pharmacovigilance in EU, US and Asia
  • Impact of the new European Pharmacovigilance legislation - Implementation and Beyond
  • Keeping abreast of the changes impacting the drug safety industry to ensure the pharmacovigilance strategies are robust and geared to compliance
  • Recent successful strategies and business models to bring out new medicines
  • How will PV activities change with Clinical Trial Transformation Initiative?
  • Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
  • Identifying essential antidote requirements and learn to implement best practices in drug safety and surveillance
  • Exploiting the pharmacy automations and technologies for enhancement of medication safety
  • Impact of technology – learn and explore
  • Latest developments in pharmacovigilance, drug safety and 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
  • Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions
  • Review the use of Periodic Safety Update Reports (PSURs) post-authorisation for safety signals
  • Dwell ahead of regulatory developments & improving your risk management strategies in a cost effective way in EU, US and Asia
  • Updating yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practice in PV
  • Accelerating new medicine introduction in developing world & overcoming challenges
  • Explaining how to use the data sources and observational research for effective safety analysis
  • Good supply chain management practices for medicine distribution
  • Be part of a major networking opportunity


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 


4th Pharmacovigilance 2013– “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

Swapu Banerjee, Deputy Managing Director & Head of Regulat, Risk & Clin. Develop, Pope Woodhead


09:40 – Morning Keynote Address 1 – Implementation of Quality in Pharmacovigilance activities

  • The legislation requirements
  • Checks made by the EMA
  • Pharmacovigilance Inspections & Internal Audits
  • The EU QPPV and Quality
  • PV system Master file and Quality

Graeme Ladds, Director, PharSafer

10:20 – Morning Keynote Address 2: UK and European Data developments for Pharmacovigilance and Pharmaco-epi, including Risk Management

John Parkinson, Director CPRD, MHRA

11:00 – Morning Coffee/Tea & Discussion


11:20 – Keynote Panel Discussion: Challenges and Opportunities

  • Greatest Challenges to PV Compliance in current market
  • Update on PV in EU, USA & RoW - Current trends for PV, and new and future guidelines – Keep yourself updated.
  • Operational implications for integration of the new European pharmacovigilance legislation for pharma
  • Litigation, risk and latest developments and trends within PV technology


Swapu Banerjee, Deputy Managing Director & Head of Regulat, Risk & Clin. Develop, Pope Woodhead


Shelley Gandhi, Director - Pharmacovigilance & Drug Safety, NDA Regulatory Services

Fiona Maini, Senior Manager, Deloitte Consulting

12:00 – Evaluating the effectiveness of risk minimization plans

  • GVP rules on evaluating effectiveness
  • Approach to meaningful evaluation, including new techniques
  • Experience of multiple successful evaluations, meeting regulators requirements will be presented
  • Pope Woodhead have innovated in validated methods for measurement of behavioural impact of risk minimisation, and this approach will also be presented

Swapu Banerjee, Deputy Managing Director & Head of Regulat, Risk & Clin. Develop, Pope Woodhead

12:40 – Networking luncheon

14:00 – Afternoon Keynote Panel Discussion: In Pharmacovigilance where does fault lie?

  • Adequate sharing of information between stake holders
  • No rapport with practising physicians & peripheral centres
  • Increasing availability of drugs, due to which too many drugs and irrational combinations and aggressive marketing
  • Irrational practice of treatment without provisional diagnosis, Wrong choice & incorrect dose, lack of documentation, resultant medical errors leading to ADEs and not necessarily ADRs
  • Pharmacovigilance Audits from a Sponsor’s Perspective:
  • Risk Management Plans (RMPS) & Risk Evaluation Mitigation Strategy (REMS)


Swapu Banerjee, Deputy Managing Director & Head of Regulat, Risk & Clin. Develop, Pope Woodhead


William Gregory, Director, Safety & Risk Management, Pfizer

Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting

John Talbot, Senior Lecturer, Pharmacovigilance, University of Hertfordshire


14:40 – Risk Management and Post Authorization Safety Studies (PASS) and the impact of the new EU legislation on both

Saad Shakir, Director, Drug Safety Research Unit

15:20 – Afternoon Tea/Coffee


15:40 – Impact of the New European Pharmacovigilance Legislation

  • Summary of the new EU Pharmacovigilance Legislation including the major changes and revisions (regulatory & industry perspective)
  • Risk Management and Pharmacovigilance Role of new PRAC - Enhanced powers and impact on drug approval, assessment of risk management plans, and product benefit-risk profile (pre- and post-market)
  • Quality and content of proactive PV and additional risk minimization activities, including the impact from new legislation

Shelley Gandhi, Director - Pharmacovigilance & Drug Safety, NDA Regulatory Services

16:20 – The Utilization of Biomarkers to Ensure Safe and Effective Therapies

Robert L Bencher, Director of Business Development, Myriad-RBM

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

Swapu Banerjee, Deputy Managing Director & Head of Regulat, Risk & Clin. Develop, Pope Woodhead

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

Mustafa A. Zaman, Senior Consultant – Integrated Product Development (IPD), PAREXEL Consulting


09:40 – Morning Keynote Address 1 – Vaccines: regulatory pathway, monitoring safety and dealing with emerging issues

  • The regulatory pathways for vaccines - planning risk management of vaccines
  • The link between vaccine quality and clinical safety throughout the product life-cycle
  • How to make best use of available data in vaccine safety evaluation, and how the new EU pharmacovigilance legislation will assist this
  • How dealing with incidents requires an integrated, multidisciplinary approach.
  • Case studies (vaccine defects/recalls, quality investigations, safety information, appropriate and timely communications)

Brij Patel, Senior Biologicals Assessor, MHRA

Bridget King, Senior Pharmacovigilance Assessor, MHRA

10:20 – Morning Keynote Address 2 – Pharmacovigilance system master file

According to new EU Pharmacovigilance Legislation (Regulation EU 1235/2010 and Directive 2010/84/EU) marketing-authorisation holders are required to maintain a Pharmacovigilance System Master File (PSMF). It must be in place at the time of initial marketing authorization application, license renewal and available for inspections. The PSMF replaced the Detailed Description of the Pharmacovigilance System (DDPS). This session will cover the requirements in the PSMF, the creation and maintenance as well as sharing a real experience focusing on some of challenges and how they can be addressed.

  • Discuss how to prepare a PSMF to meet the requirements
  • Describe how to maintain a PSMF so that it can be available within seven days from request
  • Examine challenges and possible scenarios of how to address preparation and maintenance

Geraldine Aubes, Associate Director, Pharmacovigilance, UBC

11:00 – Morning Coffee/Tea & Discussion


11:20 – Why do drugs fail? – Pre-approval stages encircling the PV guidelines

  • Analyzing & reviewing the successes & challenges of Phase I & Phase II clinical trials
  • A new medicine must comply with: good quality, effectiveness & safety for the purpose
  • Adverse reaction of drug reporting
  • Initiating follow up on adverse reports about drugs
  • Examining the post-marketing surveillance systems
  • On-going risk-benefit assessment during the post-marketing period
  • PV through pre clinical trails and practical approach to PV


Sumit Munjal, Oncology Physician & EU Region Medical Advisor –Pharmacovigilance Millennium, Takeda Oncology Company

Sarah Derry, Pharmacovigilance Manager, Diamond PV Services

12:00 – Data mining techniques in pharmacovigilance

  • Explain and apply the basic concepts and principles of signal detection in Pharmacovigilance
  • Explain the role and differences of classical and statistical signal detection in the ongoing safety surveillance of medicinal products
  • Outline how to apply signal detection within their function based on the possibilities and limitations of methodology and data
  • Employ data mining techniques to analyse large volumes of adverse event report data
  • Discuss key messages from the European Medicines Agency Guideline on the uses of statistical signal detection methods in the Eudravigilance Data Analysis System

Pipasha Biswas, Chairperson, Drug Safety & Pharmacoigilance Committee, Director & QPPV Pharmacovigilance & Pharmacoepidemiology, Symogen

12:40 – Networking luncheon

14:00 – Developing Pharmacovigilance into high quality management system and its components

  • Find out the importance of drug safety surveillance that is required to address all relevant quality
  • Communication relating to drug safety and ensuring that they are transparent and able to function efficiently in times of emergency
  • Centralized position to track quality and compliance in line with activities
  • Consistent process to monitor, analyze and resolve incidents

Irfan Ahmad, Director at Patient Safety Late Development and Marketed Products, AstraZeneca

14:40 – Audit and Inspection: Realistic steps for a successful outcome

  • How PV audit and inspection practices evolved globally and unique challenges
  • Planning targeted and routine inspections at regional level
  • Exploring practical steps to train local PV staff to meet country-specific inspection and audit requirements as well as global standards

Julia Appelskog, Pharmacovigilance Country Lead, Merck

15:20 – Afternoon Tea/Coffee

15:40 – Risk management plans in the real world

  • The new EU RMP template
  • Differences between EU RMP and REMS
  • Key challenges we now face with Global and Local RMPs 

Stephanie Jones, Medical Director, Medicorum


16:20 – A Viewpoint from Parexel: The developing regulatory framework in advanced and developing markets – for Today & Tomorrow

  • A brief recap of recent regulatory developments. Ensuring you comply with market requirements
  • Current PV practices in the EU
  • Case Studies


Mustafa A. Zaman, Senior Consultant – Integrated Product Development (IPD), PAREXEL Consulting

Hans Van Bronswijk – Vice-President (Clinical), PAREXEL Consulting

Philippe Devos PACE, Patient Safety Services, PAREXEL

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

Mustafa A. Zaman, Senior Consultant – Integrated Product Development (IPD), PAREXEL Consulting

17:10 – 18:00 – End of the 4th Pharmacovigilance 2013.

Fiona Maini

Senior Manager

Deloitte Consulting

Sarah Derry

Pharmacovigilance Manager

Diamond PV Services

Saad Shakir


Drug Safety Research Unit

Shelley Gandhi

Director - Pharmacovigilance & Drug Safety

NDA Regulatory Services

Stephanie Jones

Medical Director


John Talbot

Senior Lecturer, Pharmacovigilance

University of Hertfordshire

Robert L Bencher

Director of Business Development


Pipasha Biswas

Chairperson, Drug Safety & Pharmacovigilance Committee, Director & QPPV Pharmacovigilance & Pharmacoepidemiology


Sandy Eisen

Chief Medical OfficeR

Frontline Pharma Consulting

Graeme Ladds



Swapu Banerjee

Deputy Managing Director & Head of Regulat, Risk & Clin. Develop

Pope Woodhead

Philippe Devos

PACE, Patient Safety Services


Geraldine Aubes

Associate Director, Pharmacovigilance


Sumit Munjal

Oncology Physician & EU Region Medical Advisor –Pharmacovigilance Millennium

Takeda Oncology Company

Bridget King

Senior Pharmacovigilance Assessor


Brij Patel

Senior Biologicals Assessor


Mustafa A.Zaman

Senior Consultant – Integrated Product Development (IPD)

PAREXEL Consulting

Hans Van Bronswijk

Vice-President (Clinical)

PAREXEL Consulting

John Parkinson

Director CPRD


Irfan Ahmad

Director at Patient Safety Late Development and Marketed Products


William Gregory

Director, Safety & Risk Management


Julia Appelskog

Pharmacovigilance Country Lead



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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.
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