Regulatory Requirements for a New Active Substance: Quality

Regulatory Requirements for a New Active Substance: Quality
If you're looking to explore and understand the regulatory issues likely to arise during chemistry and pharmacy data documentation requirements to drug development, the TOPRA Masterclass is the essential course for you. Held in the InterCity Hotel Berlin, this exclusive 3-day course will cover all the major aspects you need in order for you to provide effective advice when data is prepared.




This course will cover:

  • API manufacture and in-process controls
  • CMC in the drug development programme
  • Nomenclature and characterisation of the Active Ingredient
  • Analytical methods and validation
  • Quality overall summary
  • Developing specifications for the Active Ingredient
  • Relevance of bioequivalence and bioavalability in formulation development
  • Development pharmaceutics and manufacture of the drug product
  • Stability of the drug product
  • Good manufacturing practice – supply chain considerations
  • Pharmaceutical packaging
  • Regulatory agency perspective


Intended Learning Outcomes:


Knowledge and Understanding

You will typically be able to.....

  • Demonstrate a systematic understanding of knowledge, and a critical awareness of  the theory and practice of global strategic planning strategies as they relate to obtaining regulatory marketing authorisation and pricing negotiations
  • Display critical knowledge of the regulatory requirements, global legislation, regulatory authorisation and associated documentation for planning drug development programmes
  • Demonstrate an in depth conceptual understanding of strategic plans for the regulatory approval of drug development programmes.


Skills and Attributes

You will typically be able to ......


  • Critically appraise and evaluate communications from regulatory bodies and research publications for the management of regulatory affairs and strategic planning in drug development
  • Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of drug development
  • Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding planning regulatory strategies for drug development programmes for regulatory authorisation and marketing approval.



CPD 
This course offers 16 CPD hours for successful completion. To learn about why CPD is important visit the Lifelong Learning page

Travel and accommodation is not included. You will receive information on how to book accommodation and special rates once you have booked onto the course. The special bed and breakfast rate is €99.00 plus VAT per night. 
The discounted rate is limited to six weeks prior to the start of the module and may change subject to availability, so please ensure you book as soon as possible.

Students completing MSc Regulatory Affairs: £1500.00 plus VAT £285.00 19% Total £1785.00

Non Student: £1700.00 plus VAT 19% £323.00 Total £2023.00


Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.

 
When
31/05/2017 - 02/06/2017
Where
InterCity Hotel Berlin Hauptbahnhof Katharina Paulus Strabe 5 10557 BERLIN GERMANY
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