2023-09-30 2023-09-30 , online online, 4,800 € zzgl. MwSt. Global Regulatory Affairs Manager

With this qualification course, you can continue your education in a structured manner in all global regulatory affairs topics, with a regional or country-specific focus.

Topics
    You determine the main topics of the training course yourself. Possible focal points are:
  • Approval procedures in the EU: Approval maintenance / variations, project management, labelling / artwork
  • Marketing Authorisation outside the EU: ASEAN / APAC , Japan, Latin America, China, Eastern Europe, Turkey, Iran, Iraq, Jordan and the GCC countries
  • Global CMC: Latin America, Eastern Europe, Japan, MENA, Asia, Japan and Eastern Europe, US
  • Biologics: CMC, regulatory affairs and more
  • Learning nuggets from the Pharma FORUM Webcast International
Aims and objectives
Would you like to have sound know-how in global regulatory affairs, remain flexible in terms of time and set your own professional priorities? Then this is the right place for you.

The concept: you start the qualification course with the e-Learning "Introduction to EU Marketing Authorisation". Afterwards you get a two-day training on EU marketing authorisation in the "EU Regulatory Affairs Introductory Training Course". Moreover, you select four further seminar modules (= 4 seminar days or webcast-series) that support your professional development, region- or country-specific. In this way, you qualify as a "Global Regulatory Affairs Manager" in a maximum of 18 months (or in just a few weeks) and receive certification from the FORUM Institute. In this way, you can achieve your further training goal efficiently and precisely.
Who should attend

This qualification course is aimed at employees of the pharmaceutical industry and their service providers who require in-depth know-how in global regulatory affairs.

Seminar Global Regulatory Affairs Manager

Global Regulatory Affairs Manager

Benefits
  • You receive a comprehensive EU regulatory affairs basis
  • You can individually choose 4 global regulatory affairs training modules
  • You save up to 30%
  • We follow the IMI quality criteria

Webcode 10017

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Alles auf einen Blick

Termin

Zeitraum

A few weeks to a maximum of 18 month...

A few weeks to a maximum of 18 months, depending on module booking
Veranstaltungsort

online

online

Gebühr
Ihre Kontaktperson

Dr. Rebekka Bitsch
Konferenzmanagerin Healthcare

+49 6221 500-565
r.bitsch@forum-institut.de

Details

With this qualification course, you can continue your education in a structured manner in all global regulatory affairs topics, with a regional or country-specific focus.

Topics

    You determine the main topics of the training course yourself. Possible focal points are:
  • Approval procedures in the EU: Approval maintenance / variations, project management, labelling / artwork
  • Marketing Authorisation outside the EU: ASEAN / APAC , Japan, Latin America, China, Eastern Europe, Turkey, Iran, Iraq, Jordan and the GCC countries
  • Global CMC: Latin America, Eastern Europe, Japan, MENA, Asia, Japan and Eastern Europe, US
  • Biologics: CMC, regulatory affairs and more
  • Learning nuggets from the Pharma FORUM Webcast International

Aims and objectives

Would you like to have sound know-how in global regulatory affairs, remain flexible in terms of time and set your own professional priorities? Then this is the right place for you.

The concept: you start the qualification course with the e-Learning "Introduction to EU Marketing Authorisation". Afterwards you get a two-day training on EU marketing authorisation in the "EU Regulatory Affairs Introductory Training Course". Moreover, you select four further seminar modules (= 4 seminar days or webcast-series) that support your professional development, region- or country-specific. In this way, you qualify as a "Global Regulatory Affairs Manager" in a maximum of 18 months (or in just a few weeks) and receive certification from the FORUM Institute. In this way, you can achieve your further training goal efficiently and precisely.

Who should attend

This qualification course is aimed at employees of the pharmaceutical industry and their service providers who require in-depth know-how in global regulatory affairs.

Ihr Nutzen

How to book

This course is so individual that I will be happy to advise you personally. Please contact me directly at t.mende@forum-institut.de or by phone at 06221 500 565. I will be happy to help you with the selection of modules and will also be happy to assist you with financing questions.

Your benefits

This is how you put together your individual course: You attend the basic course "EU Regulatory Affairs Introductory Training Course" (day 1 + 2) incl. preparatory e-learning on the basics of marketing authorisation. In addition you take part in 4 global regulatory affairs training modules (= seminar days) which are listed under the "optional modules" Alternative seminar modules from the area of global regulatory affairs can be selected if required: global reglatory affairs training modules

In a nutshell:

  • You receive a comprehensive basis in EU Regulatory Affairs
  • You can individually select the 4 global regulatory affairs training modules according to your focus of global or an area-/country-specific activity.
  • You have up to 18 months from the first day of the event to complete your individual further training and can also adapt the further training plan during the term.
  • You save up to 30% compared to booking individual events.
  • You will receive a FORUM certificate on successful completion of the qualification.

Optional modules

PharmaFORUM Webcast Biologics 2023

Our biotech experts will provide you with the latest information on issues related to development, quality and regulator...

jederzeit, online
Details

CMC for Biologicals

Get your know-how on creating and maintaining quality data for biotech products in our online training.

16.11.2023, online
Details

PharmaFORUM Webcast International

Our global and local experts will update you every two months with the latest regulatory and legislative developments. T...

jederzeit, online
Details

CMC requirements in Asia, Japan and Eastern Europe

Four live webcasts à 2 hours every week in March 2022: CMC requirements in China, India, Japan, South Korea and Russia/E...

jederzeit, online
Details

Mandatory modules

e-Learning: Introduction to EU Marketing Authorisation

This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketi...

Details
e-Learning
EU Regulatory Affairs introductory training course

Do you need essential European regulatory affairs knowledge? This online training course gives you a compact overview on...

Details
Online-Seminar