Overview

A unique opportunity to engage in the sharing of good practices between industry representatives and seek the advice you need from regulators.

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

The workshop 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.

On the 5th Anniversary, the committee and DIA team has put together an agenda with cutting-edge topics which will instigate to open dialogue around:

Current regional and global regulatory landscape;
The pharmacovigilance impact and strategy for vaccines, biologics and therapeutics;
Utilization of Digital Health and what implementation means for safety in the clinical and post-market space;
Sharing experience around additional Risk Minimisation
(Remote) Inspections: lessons learnt.

NEW in 2021: DIA Pharmacovigilance Hackathon

Forming teams around a hot topic in pharmacovigilance and using a facilitated design-thinking framework to identify concrete next steps and possibly answers to these important questions. Each team will be pre-formed as a multi-stakeholder unit, in order to promote an impartial dicsussion. Participants will benefit from each other's different backgrounds as a strong driver for lateral thinking and creative problem-solving with some of the brightest minds in the life sciences field.

Topics:

The Future of Pharmacovigilance: What to Keep/Change?

More information on the registration to be divulged soon.

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.

Featured topics

Pharmacovigilance Guidelines and Regulations Updates (EU, non-EU, Global)
Pharmacovigilance Changes in the UK
Harmonisation of Additional Risk Minimization Measures and Pharmacovigilance Activities
Impact of Digital Health and How it is Managed. What Medical Device Regulation Means For Pharmacovigilance
Sharing experience around additional Risk Minimisation;
(Remote) Inspections: lessons learnt.

Featured

Want to learn more about Pharmacovigilance Strategies Workshop? You've come to the right site!

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

Program Committee

Francoise Sillan, MD EU1 UK QPPV
Ipsen, France
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
Giovanna Rizzetto Senior Manager, Regulatory, Drug development and Manufacturing
EFPIA, Belgium
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
Elena Popa, MPharm Regulatory Policy and Innovation Lead
Bayer, Switzerland