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Introduction to EU Regulatory Affairs

19 - 21 November 2019

Radisson Blu Edwardian Grafton, London

This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. After three days you will have a clear understanding of the EU regulatory structure and have a solid grasp of the submission process and the standards required by the regulators.

Through interactive exercises you will gain a practical insight into the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical approach that will enable you to apply what you have learned to your daily work.

  • Speed-up the MAA through effective selection of your drug registration procedure
  • Integrate CTD requirements from the start of your submissions
  • Gain faster responses from the regulators through better negotiations
  • Compile and present the key information in your submission dossiers more efficiently
  • Maintain your license by performing post-approval obligations on time
  • Reduce early, or late stage, setbacks in the registration procedure by anticipating questions from regulators
  • Improve your dossier compilation process through a systematic data collection strategy
  • Facilitate your drug’s successful review by preparing a strong clinical profile
  • Take into consideration the patent situation when working on abridged applications

Sumaiya Patel

Sumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.

  • 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.

                                                     2017 Course Reviews

“The practical case studies which made you consider all aspects of the course was great.”

Regulatory Affairs Officer, Eurogenetics

“The fact that we got to share our experiences as well as learn from practical cases was excellent.”

Senior Manager Regulatory Affairs, Fresenius Kabi

“There was a lot of information given and a good trainer with a wealth of knowledge.”

Quality Officer QC PS, Sanquin Plasma Products BV

“I enjoyed the practical examples, case studies and discussions the most. I took the course to learn about Regulatory Affair EU Specifics and found the course definitely met my objectives.”

 Simone Machutta, Regulatory Affairs Specialist, Bayer AG

“I found the instructor was excellent when taking this course. I chose the course because of the specific topic it deals with and to gain an insight into the possibilities of what will happen to Regulatory Affairs following Brexit, as this is a big concern for Regulatory Affairs people.”

Consultant, Marla Piercy

The friendly environment and knowledge which was shared along with the resources were very helpful. Great organisation.

QA Officer (Regulatory Affairs), Phamacare Premium Ltd

The trainer is excellent, well-experienced and knows how to explain. She readily answered all our questions. Learning materials were well-structured. The group work was beneficial too.

Regulatory Affairs Manager, Novartis Croatia

Interaction between the trainer and the participants was useful and the case studies were very informative.

Regulatory Affairs Director, Ophelia Pharma 

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