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Informa

Regulatory Affairs Strategies

12 - 13 October 2020

Radisson Blu Edwardian Kenilworth, London

As senior professional you must think strategically, aligning your regulatory knowledge to the wider organisational goals and objectives.  This is critical to maintain compliance whilst managing budgets and keeping to strict business critical deadlines.  
 
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 a 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
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Figen KABADAS OGE, Msc & MBA

Figen Kabdas is Head of Regulatory Affairs with over 15 years' RA experience in both small molecules and biologics at various stages of development with specific experience within EU, US and Turkey. She earned her B.S. in chemistry and two Master's Degrees in Regulatory Affairs and In-silico Drug Development in addition to an MBA in France. 

She has extensive experience in drug development, IND, NDA, ANDA, CTA, MAA submissions, CMC, eSubmissions and life-cycle management.

She is also a well-regonized RA trainer to the industry in Turkey and she has been speaker five times in Informa GRAS conferences since 2012

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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