Pharmacovigilance: Status Quo.
Issues and Challenges in Germany and the EU
LS Academy welcomes you to the 6th German Pharmacovigilance Day to be held on 3rd June 2020 in Berlin, Germany.
Pharmacovigilance processes and activities are continuously subject to evaluation and revision based on the experience gained by marketing authorization holders and health authorities. The German Pharmacovigilance Day event will provide a status quo of the drug safety and pharmacovigilance topics that currently have a major impact in the European Union, with an emphasis on Germany.
- Among the main topics of the day:
- News from the EMA in pharmacovigilance
- Update on the EMA pilot project on signal management
- Safety concerns: challenges for risk management plans and periodic safety update reports
- Update on HaRP (Harmonisation of RMP Project): first experiences, pro’s and con’s, what should be improved
- Risk Minimisation Measures: Educational materials and “Rote Hand Brief”
- How PV can benefit from social media, artificial intelligence and apps
German and European subject matter experts will share their experience and present the challenges posed by the regulatory environment from the industry and the health authority’s perspective. Meet inspiring speakers and experts at our German Pharmacovigilance Day presenting hot-topics on safety and pharmacovigilance. Participants will have the opportunity to share their knowledge and bring practical examples to a benchmarking session at the end of the event.
The German Pharmacovigilance Day traits include:
- A Scientific Committee guaranteeing updated and strictly scientific topics, quality discussions and absence of any commercial presentations
- Different perspectives presented over the event: regulatory authorities, industry, CROs
- Each presentation is fully reviewed by matter experts before approval
- Working and open discussion sessions such as benchmarking ones
- Notable networking opportunities
- An event taking place in Berlin and presenting local and European perspectives in German
- An easy to access venue and friendly environment
The event is designed for professionals involved in safety, pharmacovigilance, clinical research, development and management of pharmaceutical products. LS Academy, leader in the field of scientific continuing education, welcomes you to an outstanding Pharmacovigilance event for constant professional development and up-to-date discussions in this extremely relevant scientific area.
Tiziana Von Bruchhausen - Senior Pharmacovigilance Writer at Boehringer Ingelheim
Boris Thurisch - Managing Director Medicine and Science, Head of the Pharmacovigilance at German Pharmaceutical Industry Association
Who should attend?
This conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care area dealing with the Pharmacovigilance system, such as: Safety and Pharmacovigilance dept, Clinical operation dept, Statistic dept, Medical Affairs dept, Medical Information dept, Regulatory Affairs dept, Quality & Compliance dept, Legal dept, Software Developing dept, Medical Devices Manifacturing Companies, University Faculties scientists who are related to clinical and medical research (Senior, Associate and Assistant Professors, Research Scholars, Phd students). Also, Directors/Seniors Directors/Executive Directors and Vice Presidents /Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of: CROs and CMOs, Clinical Research Sites, Pharma, Biotech and Medical Devices Industries.