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Regulatory Affairs Strategy

Course summary
2 days
Professional Training

Course description

Regulatory Affairs Strategy

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.

Suitability - Who should attend?

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

Outcome / Qualification etc.

Regulatory Affairs Strategy

Training Course Content

  • 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

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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Average rating 5

Based on 2 reviews

Regulatory Affairs Manager (Netherlands), GE Healthcare
Discussing with other students local ways of working was really helpful.
Regulatory Affairs Manager, GE Healthcare
The interaction and questions asked from fellow participants was useful.
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Course rating
Based on 2 reviews
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