NEXT DATE:
Sept 18-19
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A 2-day practical & interactive training:

Regulatory Affairs Strategies

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

Agenda

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.

DAY 1
9am - 5pm
  • This session will provide an insight, with practical examples, on the issues surrounding new drug development, principally as seen from a regulatory perspective.
This session will constitute the first of four case studies during which, acting as Regulatory Project Leader, delegates will take a drug through all stages of product development and registration attempting to resolve real problems. In this session delegates will prepare a TDP (Target Drug Profile) in the context of technical knowledge of their assigned products and the regulatory guidance currently available. This will be used in subsequent case studies as an objective to be achieved throughout the ‘product’s’ continued development and eventual registration.
While developing drugs there are issues, tasks, regulations & procedures that have to be considered. This session will be an opportunity to work through the following challenges:
  • Clinical Development Phase I to III : requirements and applications across the EU
  • Reconciling manufacturing, non-clinical and clinical demands within the regulatory framework and commercial imperatives
  • Guidelines on specific therapeutic areas
  • dentify study and data requirements in order to progress your product through the clinic and towards the market Advise on the clinical development programme
  • Resolve manufacturing, non-clinical and clinical problems as you strive to achieve the earliest filing date for your products MAA / CTD
  • Identify the need for, and timing of, Scientific Advice
  • Modify the Target Drug Profile (TDP) as more data become available
DAY 2
9am - 5pm
The aim of this session is to identify the main hurdles that regulatory affairs executive face during the MAA / CTD submission. It will take the form of a top level discussion where best practices will be highlighted by the trainers. Delegates will also be encouraged to put forward their questions and experiences
  • Review of key legislation including the recent Directives and regulations
  • Scientific advice from EMA and national agencies
  • What are the requirements for a successful and readily approvable MAA/CTD?
  • Selecting the registration procedure: MRP, DCP or Centralised Procedure
  • Prepare the SPC
  • Resolve the objections / consolidated list of questions with the authorities
  • Negotiate final approval
This session will demonstrate strategic approaches to help you manage your regulatory projects from initiation to completion, and assist in your objective to succeed within your organisation.
  • Regulatory Intelligence and competitive advantage
  • Optimising your product potential
  • How to be positive and a solution-seeker for your organisation -not a regulatory obstacle
  • Effective utilisation of contract service organisations
  • Regulatory negotiations at senior management level
Delegates will design a post-approval strategy to give marketing colleagues the ability to claim advantages over competitor products, and to overcome the regulatory hurdles as changes are made to the manufacturing process and the safety profile of the "product".´
This course is a cooperation with PTI - a global interactive training partner committed to the personal progression of aspiring life science professionals.
Price: £ 1.595,- / € 1.730,-
excl. 20% VAT
Book this training
Register online here
For further questions please contact us: +43 (0)1 890 57 14
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