Intellectual Property for Pharma Regulatory Affairs

Understand the impact of IP on pharmaceutical regulatory strategy

8 May 2019

& 18 Nov 2019

GBP 699
EUR 979
USD 1,090

Book now

Course overview

This practical one-day course will provide an overview of intellectual property (IP) for those working in regulatory affairs.

IP is a fundamental contributing factor to the overall regulatory strategic approach that a company may take and recognition of the different aspects of IP and influences is essential in modern regulatory affairs. Attendance will enable you to understand IP aspects and their impact and influence on regulatory strategy. Key issues covered will include patents, trade marks and copyright as well as data and market exclusivity for global pharmaceutical products. The course will also discuss the EU and FDA regulatory process, highlighting one of the fundamental differences between EU and US systems and the link to patents.

Benefits of attending:

  • Gain an overview of IP and how it contributes to a company’s overall regulatory strategy
  • Understand key IP issues including patents, copyright and freedom to operate (FTO) and how they impact on regulatory affairs
  • Discuss data and market exclusivity for global pharmaceutical products
  • Discuss EU and FDA regulatory processes, their differences and the link to patents

Who should attend?

This seminar will be of interest to development and regulatory managers working in the pharmaceutical industry. It will also be relevant to anyone requiring an overview of the key IP issues relating to regulatory affairs.


What is IP

  • An overview of:
    • Patents
    • Exclusivity
    • Copyright
    • Trade secrets
What is a patent?
  • Defining the patent
  • Uses of a patent
  • Patents and generic developments
  • Generic legislation for the EU
  • Understanding FTO
Global exclusivity
  • Data exclusivity in the US
  • Data and market exclusivity in the EU
  • Global overview of exclusivity
Influence of IP on regulatory strategy
  • US paragraph
  • Patent declaration
  • Overlap of patents and exclusivity

Product naming and trademarks

  • The influence and impact on regulatory affairs

Workshop session: FDA regulatory process and link to patents

Special cases
  • Paediatric legislation
  • Orphan drugs

Use of patents in development strategy


Andrew Willis

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He currently has a total of 32 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

Book now

8 May 2019
8 May 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
18 Nov 2019
18 Nov 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • A.A. Thornton & Co