Seminare zu Regulatory affairs & vigilance
Regulatory affairs & vigilance
Regulatory training programmes and courses
you should not miss.

Results FOR "Regulatory affairs & vigilance"


RMP and PSUR in life-cycle management: An art, not a miracle

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.

  • Bonn / 26.03.2020

Variations in Europe

Variation regulation, classification guideline, eSubmission, variation management - all processes explained in this course.

  • Amsterdam / Leiden / 02. - 03.04.2020

Scientific Writing for Medical Devices

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

The Person Responsible for Regulatory Compliance

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

eSubmission Manager in Europe

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

Biosimilars Market Access in the EU and USA

This biosimilars course addresses the available options for market access in the US and EU, including negotiating with the originator.

  • Berlin / 19.05.2020

Pharmacovigilance Requirements in Emerging Markets

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

Medical Writing in Pharmacovigilance

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

Patient Access: Early Access, Compassionate Use, Off-label Use

This seminar provides information on early access programmes, HTA requirements, CUP and off-label use in Europe

  • Frankfurt / 30.06.2020

Improve your Regulatory Intelligence (RI) Skills

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