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Regulatory Affairs for QA: Marketing Authorisations

NSF International, Pharmaceutical Services
Course summary
1 day
730 GBP excl. VAT
Manchester
Next available date: 18/03/2020 08:30 - Manchester

Course description

Regulatory Affairs for QA: Marketing Authorisations

An interactive refresher' pharmaceutical training workshop on the structure and content of the CTD and application routes specifically designed for QA Professionals.

*All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Suitability - Who should attend?

Are you looking for an interactive refresher on the structure and content of the CTD and application routes specifically designed for QA professionals? Look no further.

This workshop includes real examples of regulatory procedures and data requirements for MAA/NDA submissions in the EU/USA and other world markets. It is also relevant to medicinal products containing small molecule drug substances, biologics, generics and biosimilars, drug device combinations and borderline products.

This workshop will explore:

  • Regulatory agency expectations on the data that should be included in an e-CTD
  • What can (and often) does go wrong when too much/the wrong information is registered
  • The role of the QP/QA in managing what is registered
  • New/emerging CMC requirements – what’s coming up?

Training Course Content

By the End of This Workshop, You Will Improve/Expand…

  • Your awareness and knowledge of the latest regulatory procedures and CMC requirements for major market submissions
  • Your knowledge on how different regulatory procedures work
  • Your understanding of some of the differences between EU and US CMC requirements.
  • Your ability to communicate with your regulatory support functions

Expenses

Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

About provider

pharma training courses

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...


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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York


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