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

Results FOR "Regulatory affairs & vigilance"

SORT RESULTS

eCTD Life Cycle Management - National and Global

National dossier requirements and global life cycle management: How do they fit together? This course provides practical tips on how to professionalise your electronic dossier submission and life cycle management.

  • München / 27.02.2020

Medical Devices in Russia and the Eurasian Economic Union

This course provides you with sound knowledge in dealing with the registration and distribution of medical devices in Russia, Belarus, Kazakhstan and many other countries.

  • Frankfurt-Raunheim / 27.02.2020

HOT TOPICS Drug/Device Combination Products

This conference addresses the new regulatory framework for drug-device combination products. Use this opportunity to discuss the impact these changes will have on your products and how to implement the requirements.

  • Amsterdam / Leiden / 02. - 03.03.2020

Regulatory Affairs China

Two experts will give you an in-depth update on your duties with regard to accepted clinical trial data, dossier submission and the post-approval processes.

  • Frankfurt / 17.03.2020

ASEAN & Chinese CTD/eCTD

CTD Dossier and submission in Asia, the ASEAN countries and especially China discussed in detail at this seminar

  • Frankfurt / 18.03.2020

CMC Documents: Scientific writing for regulatory submission

How to write the Module 3 for Regulatory Submission - Here you will get in-depth information.

  • Köln / 19.03.2020

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

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
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