Overview

DIA’s mission – to work across the healthcare continuum to ensure patients receive the therapies they need – is more essential than ever during times like these. DIA acknowledges the time and effort that has gone into planning and preparing for DIA’s Pharmacovigilance Strategies Workshop, and trusts that everyone will understand the need to respond to current, evolving health concerns in a responsible manner. These precautions are being taken to ensure the health and safety of our entire, global DIA family.

DIA is committed to exploring all possible avenues to provide a productive setting and a fulfilling meeting experience. We appreciate your patience as we work through any potential challenges.

DIA has a long history of working closely with Industry and Regulators to bring topics and speakers together with broad audiences in order to create stimulating and relevant discussion.

Join the DIA Pharmacovigilance Strategies Workshop to discuss the current landscape and join intense and well-lead discussion that may help you to progress your knowledge and practices.

The conference format is designed to stimulate dialogue and generate solutions through a series of interactive sessions and workshops conducted in an informal setting allowing for in-depth discussion in smaller groups.

Featured topics

EMA GVPs Updates
Medical Device Regulation: Impact on Pharmacovigilance
Implementation of EU Clinical Trial Regulation
Inspections and Audits
Signalling Management
Additional Pharmacovigilance Activities
Risk Minimisation Measures and Risk Communication
Future of Pharmacovigilance

Who should attend?

Established professionals who are seeking to increase their network of like-minded colleagues; share their thoughts and practices with others; learn the most current regulatory views and gain practical knowledge in key areas in pharmacovigilance, including:

Signal management
Data Privacy
Risk Management Planning
PSMF maintenance
Clinical Trials

Professionals involved in:

Drug Safety/Pharmacovigilance
Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
Benefit-risk assessment and communication
Medical Product Safety Assessment
Regulatory Affairs
Clinical Trials
Pharmaceuticals, biologics, combination products, devices
Clinical Research and Clinical Research Organizations
Health Outcomes
Academic Research Centers
Regulatory Agencies

Learning objectives

Seek direct answers to the business challenges you are facing every day
Understand how other organisations are managing through the shift of sharing all information to sharing relevant information
Understand the regulators expectations for signal assessment, risk management planning, and risk communication
Ensure that your pharmacovigilance work matches up with inspector expectations and delivers the efficient outcomes for patients.

Short Course or Primer

To keep you at the forefront.

Oct 29, 2020

Workshop:

The PSMF in 2020 - General Developments In - and Outside Europe

Learn more

Oct 29, 2020

Workshop:

The PSMF in 2020 - General Developments In - and Outside Europe

Learn more

Program Committee

Wendy Huisman, PharmD Director
Vigifit, Netherlands
Shahin Kauser Leading Senior Scientific Assessor
MHRA, United Kingdom
Maarten Lagendijk, MSc Deputy EU QPPV
MSD, Netherlands
Bianca Mulder, PharmD, MPharm, MSc Pharmacovigilance Assessor
Medicines Evaluation Board, Netherlands
Elena Popa, MPharm Regulatory Policy and Innovation Lead
Bayer, Switzerland
Francoise Sillan, MD EU1 UK QPPV
Ipsen, France
Mette Stockner, MD Senior Pharmacovigilance Director
Savara ApS, Denmark
Willemijn van der Spuij, MSc Executive Director, WorldWide Patient Safety International, Europe
Switzerland
James Whitehead, MBA, MSc Senior Director, Device & Digital Safety
AstraZeneca, United Kingdom