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Informa

Regulatory Affairs Strategies

17 - 18 September 2019

Radisson Blu Edwardian Grafton, London

This course has been designed to help you select the best registration strategy depending on the product area and indication. Submissions are delayed because of lack of CMC / non-clinical / clinical data, inaccurate indications being submitted, and inappropriate procedures being used. The financial consequences are potentially devastating.

This interactive 2-day course will provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams and strategies that work for both you and the regulators.

  • Formulate regulatory strategies that achieve first class regulatory performance and compliance
  • Speed up drug registration through skilled utilisation of registration procedures
  • Reconcile R&D, clinical and marketing demands within the regulatory framework
  • Manage the practical hurdles of submitting MAA/CTD within the deadlines
  • Negotiate and respond to Regulators’questions successfully
  • Understand the impact for your RA strategy of your product’s therapeutic area, proposed indications and other technical and development features
  • Collect and present key information for the submission dossier to achieve a winning strategy
  • Make the most out of the Centralised, Decentralised and MR procedure and get fast approval from Regulators

Dr. Salma Michor, MBA, CMgr, RAC

Previously, Salma has worked for Chiesi-Torrex, Wyeth Whitehall and for Croma Pharma, where she was director of supporting operations, supervising regulatory affairs and compliance, change control and lifecycle management, pharmaceutical editing and packaging and the medical department. Michor Consulting has served among others such clients as Johnson & Johnson, Novartis, Valeant Pharma, Baxter AG, Almirall, UCB and Colgate Palmolive.

This course is relevant for anyone working within the field of regulatory affairs at management level or above, such as:

  • Regulatory Affairs Specialist
  • Regional Coordinator
  • Regulatory Affairs Associate
  • Development Pharmacist
  • Pharmacovigilance Manager
  • Regulatory Affairs Attorney
  • Regulatory Affairs Executive
  • Project Managers
  • Regulatory Affairs Manager
  • Strategy Management
  • Regulatory Affairs Officer
  • Quality Manager

 

I enjoyed learning through the case studies. The course content was excellent.

Pharmacist, SFDA


The interaction and questions asked from fellow participants was useful.

Regulatory Affairs Manager, GE Healthcare


Discussing with other students local ways of working was really helpful.

Regulatory Affairs Manager (Netherlands), GE Healthcare


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