Tips & tricks for managing periodic reports and risk management plans post marketing authorisation. Furthermore insights into global PV document management will be given. Thus the training course gives you an allround overview.
Variation regulation, classification guideline, eSubmission, variation management - all processes explained in this course.
- Amsterdam / Leiden / 02. - 03.04.2020
This course will show you how to write scientific documents such as a clinical evaluation in good and readable English that is appropriate to your audience, while complying with the regulatory requirements.
- Hannover / 13. - 14.05.2020
How to prepare effectively for the responsibilities of a person responsible for regulatory compliance (PRRC). This and more in our seminar!
- Amsterdam / Leiden / 14.05.2020
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD.
- Amsterdam / 18. - 19.05.2020
This biosimilars course addresses the available options for market access in the US and EU, including negotiating with the originator.
The diversity of PV-relevant regulations defining the art of good PV practice call for a finely tuned balance to ensure that all PV systems employed by a company tie into a unified and truly global PV matrix. Our experts in this course will give you a detailed update on the current legal and regulatory background and on your duties.
- Frankfurt / Niederrad / 15. - 16.06.2020
This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.
- Frankfurt / 18. - 19.06.2020
This seminar provides information on early access programmes, HTA requirements, CUP and off-label use in Europe
After having attended this course, you will be aware of the key components of RI and its practical use in your role as a regulatory professional.
- Frankfurt-Raunheim / 03.07.2020