Pharmacovigilance & Risk Management Strategies

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Pre-conference workshop

25 January

Introduction to the training: GVP Module V – Risk Management Systems
Managing risk across a products life-cycle
Creating a risk management plan
Evaluating effectiveness of RMMs
Best practices for risk minimisation activities

Day 1

26 January

Keynote: Cooperation between regulatory bodies and the industry
GVP guidelines updates
A regulatory overview of the most common mistakes at PV inspections
Roundtable discussions
Updates from PRAC
Implementation of the ISO IDMP standards
Regulatory panel discussion
Case study: IT optimization, automation and digitization - building cost effective and scalable systems

Day 2

27 January

Spotlight session: Regional interpretation of PV concepts by the 3 ICH regions
PV Harmonization in LATAM
Rapid growth of Pharmacovigilance in emerging markets: Detailed look at India and Africa
Effectively managing Pharmacovigilance on a global scale
Case study: Leveraging social media, mobile technologies and e-health for a proactive approach to PV
Panel discussion: Improving drug related safety risk communication with patients
Pharmacovigilance from the point of view of a Patient Safety professionals
Problem solving roundtables