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Hilton London Docklands Riverside Hotel

Oct 26, 2018 8:30 AM - Oct 26, 2018 4:30 PM

265 Rotherhithe Street , London, SE16 5HW, United Kingdom

Risk Management and Minimisation Workshop

Interactive format with hands-on discussions and activities related to RMP.

Overview

Risk Management, including risk minimisation, is receiving more and more attention from regulators and industry. It is a point of interest for the stakeholders to have a better understanding on this topic.

This hands-on workshop will explore in more detail the practical implications.

Topics have been carefully selected from the feedback received by past attendees from EMA Infodays and DIA RMP events. The agenda will explore in detail topics covered at the EMA Risk Management Plan Information Day on 25 October.

The interactive format will reinforce learnings and illustrate how to apply them to the development and implementation of EU-RMPs, involving case studies and worked examples.

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Who should attend?

Professionals working within the pharmaceutical industry in pharmacovigilance, drug safety, regulatory and medical affairs or similar positions, who are involved in in risk management planning, risk minimisation development or risk communication at small to medium enterprises (SMEs), MAAs / MAHs for generic products, MAAs / MAHs for innovator products and Contract Research Organisations (CROs)

Also, attendees of the EMA Risk Management Plan Information Day and others who wish to practically apply the topics covered to the development of EU-RMPs.

Program Committee

Patrick Batty
Medicines and Healthcare Products Regulatory Agency, United Kingdom
Steve Mayall, PhD Director
Huron Consulting Group, United Kingdom
Jan Petracek, MD, MSc CEO
Ivigee, Czech Republic

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