We are in the midst of a breathtaking series of changes in the world of pharmacovigilance, both within Europe and beyond and this has prompted new challenges for all stakeholders. The implementation of the new EudraVigilance system; reexamination of the way we assess and present safety concerns for authorized products; the intensification of evolving PV requirements in non-EU markets and the increasing complexity of business models leading to challenges in communication and oversight are just some of the things that this conference will address.
Pharmacovigilance is uniquely placed to nurture sharing of good practice between industry representatives and seeking advice from regulators and inspectors as we all strive to improve the way we manage patient safety and comply with legislation.
DIA have 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 Conference to discuss the current landscape and join intense and well-lead discussion that may help you to progress your knowledge and practices in the following areas:
- Pharmacovigilance System Master File – keep up with evolving legislation
- EudraVigilance (EV) system: practices and challenges
- Brexit consequences for pharmacovigilance procedures
- Signaling and access policy to the EV database
- Real World Data: a challenge for industry and pricing assessment.
- Experiences with GVP Module V Rev2
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.
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
- Risk Management Planning
- PSMF maintenance
Gaby L. Danan, DIAFellow, MD, PhD • Pharmacovigilance Expert
Margaret Anne Walters • Deputy EU Qualified Person for Pharmacovigilance
Merck, Sharp & Dohme Ltd, United Kingdom
Maria Wishart • Deputy EU QPPV
Astrazeneca, United Kingdom
Joanna Harper • Expert Inspector, GPvP, Inspectorate, Enforcement and Standards
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Reena Harjai, MD • Director, Pharmacovigilance
APCER Life Sciences, United States