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
Short Course or Primer
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Oct 29, 2020
Workshop: The PSMF in 2020 - General Developments In - and Outside Europe: Where are we Heading?
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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.
Program Committee
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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 • VP GPS TA ENDO-ONCO & EU 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, MSc • Patient Safety Medical Device Lead
Astrazeneca, United Kingdom
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Preconference Workshop:
The PSMF in 2020 - General Developments In - and Outside Europe: Where are we Heading?
