PTI is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

Regulatory Affairs Strategies

2020 Dates TBC

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

Figen Kabdas MSc (Regulatory Affairs) & MBA

Figen Kabdas is a Senior Regulatory Affairs Consultant & Trainer with over 13 year's experience in Regulatory Affairs for generics, vaccines and biosimilars with specific expertise in the EU & US markets including Turkey, the Middle East and Asia Pacific. Since 2012, Figen has been delivering expert training to the Pharmaceutical industry and has been a guest speaker at International Regulatory Affairs conferences.

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


You may also be interested in...