Overview
Engage in the sharing of good practices between industry representatives and seek advice from regulators in this unique workshop
Linking Industry and Regulators in stimulating discussions is what makes the DIA community special. Join the DIA Pharmacovigilance Strategies Workshop to benefit from the outstanding knowledge of our excellent speakers, sharing their insights and best practices.
Finally, back in a face-to-face format, you get the opportunity to broaden your network and meet key-stakeholders from regulation and industry in person.
The workshop format is tailored to stimulate dialogue and generate solutions through interactive sessions and workshops. Enjoy an informal setting with in-depth discussions in smaller groups.
Expect cutting-edge topics, selected by the committee and the DIA team.
More detailed information about this event will be shared soon. Stay tuned!
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 discussion. 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.
More information on the registration to be divulged soon.
Featured topics
- Pharmacovigilance Guidelines and Regulations Updates (EU, non-EU, Global)
- Globalisation of PSMF : Practical Implementation
- Lessons Learnt from the Experiences with COVID-19 Vaccines
- Workshop: Future Changes and Challenges in PV
- Data Science and Standards : Impact on Pharmacovigilance
- Social Media and Patient Support Programmes
- Medical devices, wearables, combination products
- Cooperation between marketing authorisation holders
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 Intelligence
- Clinical Trials
- Pharmaceuticals, biologics, combination products, devices
- Clinical Research and Clinical Research Organizations
- Pharmacoepidemiology
- Academic Research Centers
- Regulatory Agencies
Learning objectives
- Connect with experts and colleagues in pharmacovigilance
- Learn in an interactive format through exchange of ideas and in-depth discussion
- Understand the regulators’ expectations around pharmacovigilance and how to manage these
- Find the answers to the day-to-day challenges you face
- Exchange experiences, and contribute to solutions
Program Committee
-
Maarten Lagendijk, MSc • Deputy EU QPPV
MSD B.V., Netherlands -
Bianca Mulder, PharmD, MPharm, MSc • Pharmacovigilance Assessor
Medicines Evaluation Board, Netherlands -
James Whitehead, MSc • Patient Safety Medical Device Lead
Astrazeneca, United Kingdom -
Francoise Sillan, MD • VP GPS TA ENDO-ONCO & EU QPPV
Ipsen, France -
Wendy Huisman, PharmD • Director
Vigifit, Netherlands -
Shahin Kauser • Leading Senior Scientific Assessor
MHRA, United Kingdom -
Willemijn van der Spuij, MSc • Executive Director, WorldWide Patient Safety International, Europe
Bristol-Myers Squibb, Switzerland -
Claudia Ferreira • Scientific Programs Team
DIA, Switzerland
