Meet...

Andrew Willis

Presenter

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 has over 30 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.

Andrew Willis’s courses

  • 30 Sep • 2 day course

Biosimilars

Live online

  • 07 Oct • 2 day course

The FDA Drug Approval Process

Live online

  • 13 Oct • 2 day course

Pharmaceutical Development of ATMPs

Live online

  • 15 Oct • 2 day course

Variations to Marketing Authorisations

Live online

  • 24 Nov • 2 day course

The Common Technical Document

Live online

Reviews for Andrew’s courses

Speaker is a very knowledgeable and engaging. There was a wealth of information provided in this course.

13 Jan 2025

The Common Technical Document

[Speaker] answered all the questions, and the discussions were super helpful. Very satisfied. Would recommend.

2 Dec 2024

The FDA Drug Approval Process

Very informative. Engagaement with participants was great.

28 Nov 2024

Variations to Marketing Authorisations

Presenter is very knowledgeable and is able to communicate that. [I particularly enjoyed] small group, presenter stimulated interaction.

14 Oct 2024

Pharmaceutical Development of ATMPs

Good webinar, presentation and excellent speakers

27 Jun 2024

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

I was hoping to gain a better understanding of the US approval process as I currently work on EU registrations but am moving to a more global role. The webinar covered the US process really well and I don't feel there was anything missed.

12 Jun 2024

The FDA Drug Approval Process

I was looking for a refresher on variation management in EU.
This was provided in a very good and structured way, with several tips and tricks to consider when dealing with variations.

10 Jun 2024

Variations to Marketing Authorisations

Very good webinar. The schedules were good and respected. The content meets my expectations

10 Jun 2024

Variations to Marketing Authorisations

The speakers were highly engaging and delivered the content in an interactive manner, which greatly enhanced the learning experience. Their expertise and ability to facilitate discussion made the webinar both informative and enjoyable.

10 Jun 2024

Variations to Marketing Authorisations