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The Benefit/Risk Ratio: Pharmacovigilance, Medical And Regulatory Converge: 2-Day Workshop

Marco Anelli, R&D Director at Keypharma srl - Product Life Group
Zurich, Switzerland
| Thursday, December 15, 2016 | Friday, December 16, 2016

Course Description:

In this two day workshop conference we will review requirements of EMA and EU regulatory authorities. The course will focus on the laws and regulations for Pharmacovigilance during Pre-marketing and Post-marketing (EMA, GVP, ICH). Attendees will get different points of views on Regulatory, Scientific, Ethical, Marketing and understanding about the role of GVP (Good Vigilance Practice). You will learn to design complete strategy for PSUR/PBRER.

Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities.

The concept of “benefit/risk” ratio (no longer “risk/benefit”) has become the common denominator not only of pharmacovigilance (PV), but also of practically all drug-related regulatory activities, throughout the life cycle of a medicine, from preclinical to post-marketing.

This is a very scientifically sound approach and is also in line with the current clinical practice, however, it has made PV activities significantly more complex, since it implies that all data/information/knowledge about a drug have to be put in context before being analysed and acted upon.

The focus, in fact, has shifted from an “event-based” approach, i.e. making sure that all necessary data were properly and timely collected, to an approach in which the adequacy of information was somehow “taken for granted” and a much greater emphasis was placed on what could be done with such information.

As a matter of fact, in the past few years drug companies – especially the major ones – have been required to put a lot of effort and resources on activities like signal detection and signal management. In addition, Product Safety Update Reports (PSURs) and Risk Management Plans (RMPs), for a certain period considered essentially as “formalities”, have recently been analysed and criticized by Regulatory Authorities, in greater and greater depth.

This process - which could be summarized in the phrase “from data to knowledge to action” - has continued in the following years, too.
The RMP and the PSUR can be also considered as a “proactive PV” attempt, since it gives great importance not only to what we know about a drug, but also to what we do not know and to what can be done to minimize the possible consequences and/or to fill the gaps.

The preparation of such documents – in the most consistent and cost/effective way - now requires a relevant level of cooperation among the different departments of a Pharma company, and a “knowledge base” (vs. a “data based”) approach, which is the object of this two-day course.

Learning Objectives:

Upon completing this course participants should:

  • Understand the concept of benefit/risk (B/R) ratio, also in the light of the existing EU regulations
  • Evaluate the data/information available on the B/R ratio of a drug
  • Critically examine the different “Regulatory” and “Pharmacovigilance” documents pertaining to the different phases of the life cycle of a drug.
  • Perform a “gap analysis” of the existing documentation
  • Plan the different phases of the preparation of a PSUR/RMP

Who Will Benefit:

This course is designed for people involved in the preparation/supervision/coordination of the regulatory/PV documents pertaining the different phases of the life cycle of a drug, in particular:

  • Medical Affairs
  • Medical Departments
  • Regulatory Affairs
  • Pharmacovigilance
  • Medical Writing

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Course Outline:

Day One (8:30 AM – 5:00 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM


  1. The Benefit-risk ratio: definition
    1. An ever-changing situation
    2. The position of EMA and EU regulatory authorities
  2. Pharmacovigilance:
    1. Definition
    2. Laws and regulations
      1. Pre-marketing
      2. Post-marketing (EMA, GVP, ICH)
    3. Different points of views:
      1. Regulatory
      2. Scientific
      3. Ethical
      4. Marketing
  3. The role of GVP (Good Vigilance Practice)
    1. Definitions
    2. Efficacy and effectiveness: from trials to real world
    (guided group activity/test)
  4. Overview of regulatory documentation on benefit-risk ratio:
    1. Investigator’s Brochure
    2. DSUR
    3. Clinical Trial Report
    4. CTD (Module 2.5 Clinical Overview and Addendum to the Clinical Overview)
    5. RMP
    7. Clinical trial report
  5. Referrals
    1. The background
    2. Different types
    3. How to approach a referral
  6. Advantages of a unified “knowledge management” approach
    1. From data to knowledge
    2. From knowledge to documents
    3. The CCDS/CCSI
  7. Sources of data:
    1. Internal database(s)
    2. Literature
    3. Clinical trials
    4. How to collect information
    5. Simple stats and meta-analyses
      1. Evidence levels
      2. Free tools
  8. Practical exercise (real-life example from participants are welcome)


  1. Again on sources of information (and their usefulness):
    1. Internal databases
    2. Clinical trials
    3. Literature
      1. AHFS
      2. Martindale
      3. PubMED
      4. Google Scholar
      5. Medline
      6. EMBASE
      7. Toxnet
      8. RTECS
  2. The new approach to Literature Searches
    1. Medical Literature Monitoring
  3. Literature reviews
    1. Cochrane reviews
  4. Signal detection
    1. A necessary tools
    2. Possible approaches
  5. Structure and contents of PSUR
    1. Detailed analysis
  6. PSUR-RMP comparison
  7. PSUR/ Addendum to Clinical Overview comparison
  8. How to analyse a PSUR
    1. What should be in there
    2. Two “real life” examples
  9. How to prepare a PSUR:
    1. The knowledge based approach
  10. How to prepare a PSUR:
    1. Checklist(s)
  11. How to prepare a PSUR:
    1. General considerations
    2. “image” considerations
  12. From theory to reality
    1. How to prepare a PSUR:
      1. Planning
      2. “project management”
  13. Practical exercise

Meet Your Instructor

Marco Anelli,
R&D Director at Keypharma srl - Product Life Group

Marco Anelli has been appointed in January 2016 "Head of Pharmacovigilance and Medical Affairs Advisory Services" at Product Life Group, an international consultancy company.

Prior to this, Marco was working as R&D Director at Keypharma, an Italy-based ProductLife Group company, and was responsible for the coordination of all clinical and preclinical aspects of projects run internally and on behalf of clients.

Drawing on a career in the pharmaceutical industry that spans 25 years, Marco provides expert oversight on a wide range of R&D and Medical Affairs related activities. Marco has participated in and coordinated all stages of drug development -- from formulation to Phase I-IV and pharmacovigilance. In addition, Marco is a qualified QPPV and has prepared and overseen more than 200 non-clinical and clinical overviews and summaries.

Before joining Keypharma and PLG, Marco was Medical Affairs Director at Eurand. In recent years, has worked extensively in the fields of pharmacoeconomics and health technology assessment. He has a medical degree from Milan University, specializations in Medical Statistics and Clinical Pharmacology from Pavia University and an international master's degree in health economics and pharmacoeconomics from Pompeu Fabra University in Barcelona.

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Seminar One Registration (USD)

December 15-16, 2016, Zurich, Switzerland
(For Registrations till October 5, 2016 - $1899)
(For Registrations till November 10, 2016 - $1999)
(For Registrations till November 30, 2016 - $2099)
(For Registrations after November 30, 2016 - $2199)

You Save: $2,595.00 (22%)*

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December 15-16, 2016, Zurich, Switzerland
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