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

Results FOR "Regulatory affairs & vigilance"

SORT RESULTS

PV audits & inspection strategies - Day 1: Risk based PV audits

Our experts will help you to identify risks in your PV system and will provide you with helpful methods to adjust your audit processes and strategies.

  • Bonn / 29.09.2020

PV audits & inspection strategies - Day 2: Pharmacovigilance Inspection Readiness

Our course will provide insights into the current pharmacovigilance inspection strategy in Europe. Learn all you need to know about the differences in the inspections and about the different requirements in this training.

  • Bonn / 30.09.2020

PharmaFORUM Webcast Biologics "Future digitalisation trends in submission and labelling"

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

  • Online /

PharmaFORUM Webcast International

Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!

  • Online /

Webcast Series: Legal Issues in Regulatory Affairs

These recorded six webcasts enable you to deal with the legal challenges in marketing authorisation and life cycle management.

  • Online /

e-Learning: Introduction to EU Marketing Authorisation

This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).

  • Online /

e-Learning: Marketing Authorisation Outside the ICH Region

This e-learning will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements. Dossier requirements in Australia, Hong Kong, India, South Korea, Taiwan, Saudi Arabia, GCC, Jordan, Turkey, Thailand, China, South Africa, Russia, Kazakhstan, Eqypt, Brazil, Mexico & Argentina will be addressed

  • Online /

e-Learning: Common Technical Document & eCTD

Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.

  • Online /

e-Learning: EU Variation System & Procedures

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.

  • Online /

eCTD preparation and submission

This online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.

  • Online /
...
Pagination