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Informa
Starting 9 November 2020

4-week online academy

Gain a comprehensive understanding of the EU regulatory framework for drug development and dossier submission

Course Overview

The pharmaceutical and biotech industries are the most regulated in the world due to the nature of the product. Patient safety is central to all decisions, processes, procedures, guidance and regulations. Regulatory agencies such as the MHRA and EMA are in place to ensure new and existing products meet stringent safety requirements. As a professional working in the sector it is important for you to fully understand the regulations

This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. Over 4 weeks and 8 modules you will gain a clear understanding of the EU regulatory structure and a solid grasp of the submission process including the standards required by the regulators.

This course will give you a practical insight into the European regulatory environment throughout the whole product life cycle including: non-clinical and clinical studies, the various submission procedures, labelling and packaging, post-MAA obligations and activities and more.

Online Academies

Pharmaceutical Training International online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 4 weeks students will learn through:

  • 8 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

What will you learn?


Marketing Authorisation
Marketing Authorisation

Gain a complete overview of the EMA and the various types of MAAs.

Regulatory Affairs
Regulatory Affairs

Understand the regulatory affairs throughout the product development including R&D, manufacturing, clinical trials and PV.

Clinical Trial Approval Process
Clinical Trial Approval Process

Learn the procedures for gaining clinical trial approval and appreciate the importance of GCP.


CT Regulation
CT Regulation

Gain an insight into the new CT Regulation and to prepare for future changes.

Drug Dossier Application
Drug Dossier Application

 Discover what goes into a drug dossier application to ensure speedy approvals.

CTD
CTD

Examine the CTD with a detailed focus on the CMC/quality module, non-clinical study reports module and clinical study reports module.


Key Regulatory Differences
Key Regulatory Differences

Appreciate the difference between pharmaceutical and biopharmaceutical products and compare the key regulatory differences.

Packaging and Labelling
Packaging and Labelling

Understand the requirements of packaging and labelling pharmaceutical products in the EU.

Post approval product filing
Post approval product filing

Learn how to file for variations in your product post approval for efficient life cycle management.


Pharmacovigilance
Pharmacovigilance

Gain a solid grounding in pharmacovigilance and understand the importance of building a PV strategy to maintain patient safety.

Who is this course for?

Those new to Regulatory Affairs or wishing to update their knowledge on European regulatory affairs

  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
  • Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others)
  • Regulatory Affairs, Registration and Documentation Assistants/Officers/Managers
  • Those in other areas of the pharmaceutical industry such as development or manufacturing
  • Project Management who would find knowledge of the regulatory environment useful


Find out more about online academies...


PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

On average, delegates of our online academies said...

4/5
for quality of content
85%
applied content during the course to their role
4/5
for quality of delivery

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.