Global RA Manager

Modular e-Learning and webcast programme

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Modular e-learning and webcast programme: Global Regulatory Affairs Manager

  • Do you need to understand regulatory affairs principles outside the EU?
  • Do you need country-specific regulatory affairs expertise?
  • Do you need training tailored to your needs?
This online training addresses the needs of regulatory affairs managers dealing with marketing authorisations outside the EU or planning to do so in the future.

The introductory e-learning course provides you with a good overview of ROW regulatory requirements, which you can intensify in the subsequent three webcasts. You can select the webcast modules according to your countries of choice.

After passing the online multiple-choice test for each training module you receive a certificate.

   Download the brochure here.


 

Contact
https://img.forum-institut.de

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Benefits

Your benefits at a glance

  • Modular online training tailored to your needs
  • Choice of three webcast modules according to your countries of choice
  • Learn at your own pace – wherever and whenever you want
  • Pass the online multiple-choice test for each training module and receive a certificate
  • Pay 25% less with this package

 

 

   

How does it work?

1. Choose the most suitable webcasts and register by email or telephone.
2. Receive an email with your log-in data for our learning platform.
3. Log in and start your online training programme.
4. Receive a certificate once you have successfully completed all the tests.

Your programme

Commencement of training
 

'Marketing Authorisation Outside the ICH Region' e-learning course

This e-learning course will familiarise you with regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements.


Choice of three webcasts from our
PharmaFORUM Webcast International’ series


Orphan drug legislation and paediatric development – legal framework
  • Paediatrics development programme: When is it essential? Is a PIP waiver or deferral possible?
  • Orphan designation – legal framework and the consequences for the development programme

Webcast by Sita Schubert, 9/2019, two hours of learning content and one assessment


Clinical trials in China
  • Chinese regulatory authorities overview
  • CTA procedures including CTA filing and approval
  • CTA relevant requirements, such as CTA dossier preparation, foreign clinical trial data acceptability, interaction with authorities

Webcast by Yingying Liu, 9/2019, two hours of learning content and one assessment


Pharmacovigilance in Russia
  • Legal background and national authorities
  • Local PSMF
  • EAEU QPPV
  • PV inspections
  • Future trends

Webcast by Anna Kramar, 7/2019, two hours of learning content and one assessment


Regulatory Affairs in Mexico
•    Regulatory affairs and pharmacovigilance in Mexico
•    Regulatory requirements and differences to European framework

 
Webcast by Anita Patel, 5/2019; two hours of learning content and one assessment


Dossier requirements in the Middle East
•    Acceptance of the CTD, eCTD and other formats
•    Focus: Saudi Arabia, Oman, UAE, Bahrain, GCC, Jordan

 
Webcast by Dr Mohammed Saleem, 4/2019; two hours of learning content and one assessment


Regulatory Affairs and PV in Brazil
•    National procedures
•    NCEs, NBS and Generics
•    Maintenance: variation and renewal

 
Webcast by Anita Patel, 3/2018; two hours of learning content and one assessment


Regulatory Affairs in China
•    Essential documents for an application
•    Maintenance duties

 
Webcast by Dr Alan Chalmers, 5/2018; one hour and 15 minutes of learning content and one assessment


Marketing Authorisation in the US
•    Marketing authorisation procedures
•    Dossier requirements and communicating with authorities

 
Webcast by Dr Ulrich Granzer, 7/2017; one hour and 45 minutes of learning content and one assessment


Regulatory Affairs and PV in Saudi Arabia
•    Module 1 CTD with regional peculiarities
•    Saudi vigilance system & QPPV

 
Webcast by Dr Mohammed Saleem, 9/2017; two hours and 15 minutes of learning content and one assessment


Russia as Part of the New EAEU – Changes in Regulatory Affairs
•    National registration procedures
•    Regulations in the EAEU

 
Webcast by Dr Edelgard Rehak, 11/2017; one hour and 45 minutes of learning content and one assessment


Marketing authorisation in Turkey
  • How to become a marketing authorisation holder in Turkey
  • Marketing authorisation application & procedure
  • Localisation, local GMP inspections and further topics


Webcast by Seda Kadioglu; 11/2019; two hours of learning content and one assessment


Marketing Authorisation in Australia


Webcast by Greg Plunkett; 01/2020; one hour and 35 minutes of learning content and one assessment


Global eCTD Lifecycle Management
  • Change Management and Variation Management
  • Further product development and the challenges in eCTD
  • National eCTD peculiarities in a global environment


Coming soon (07/2020)
Webcast by Remco Munnik


Regulatory Affairs in EAEU
  • Update Customs Union
  • MRP, DCP
  • Cessation of national procedures


Coming soon (09/2020)
Webcast by Anna Kramar

 

Fee & free Demo Account

The fee for a single account, which is valid for 12 months, is €990 (excluding German VAT). You may access the modules as often as you want during this time. You will be awarded a certificate of completion at the end.

If you are interested in a free demo account please use the form below.

CONTACT & QUESTIONS

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