Upcoming training: “Pharmacovigilance, back to basics Masterclass”
Our Regulatory Information Director, Remco Munnik, will be one of the speakers at “Pharmacovigilance, back to basics Masterclass”, focusing on the following topics:
Electronic submission of the new Pharmacovigilance Legislation, xEVMPD.
- Update on Article 57 xEVMPD data requirements and status
- Implementation of ISO IDMP
- Status of the PSUR repository
The complete course presents the regulatory environment for the pharmaceutical industry along with numerous directives, regulations and guidelines. It is an opportunity to learn pharmacovigilance by working on case studies. At the end of the course it will be possible to produce practical advice and develop adequate strategies to handle reporting requirements.
This event will be held on September 17th -18th, in the h10 Casanova Hotel, Barcelona.