FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505

Global RA Manager

Modular e-Learning and webcast 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
Coming soon (in November 2019)
Two hours of learning content and one assessment
 
Auszeichnungen und Kooperationspartner
 
 

CONTACT

Dr Henriette Wolf-Klein

Head of Department

+49 6221 500-680

h.wolf-klein@forum-institut.de