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Andrew Willis

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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.

Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

23 Sep 2020

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

Drug/Device and Device/Drug Combinations in the EU and USA

24-25 Sep 2020

Practical guidance on borderline Issues and combination products

Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

5-6 Oct 2020

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Biosimilars Training Course

Biosimilars

6-7 Oct 2020

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

8-9 Oct 2020

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

17-18 Nov 2020

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Common Technical Document Training Course

Common Technical Document

1-2 Dec 2020

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

10 Mar 2021

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

11-12 Mar 2021

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

17 Mar 2021

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

18-19 Mar 2021

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

22-23 Mar 2021

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Biosimilars Training Course

Biosimilars

23-24 Mar 2021

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

25-26 Mar 2021

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

29-30 Mar 2021

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Biosimilars Training Course

Biosimilars

30-31 Mar 2021

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

7-8 Apr 2021

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

5-6 May 2021

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

11-12 May 2021

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Common Technical Document Training Course

Common Technical Document

2-3 Jun 2021

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Common Technical Document Training Course

Common Technical Document

9-10 Jun 2021

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

20-21 Sep 2021

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

22 Sep 2021

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

The FDA (Food and Drug Administration) Drug Approval Process Training Course

The FDA Drug Approval Process

27-28 Sep 2021

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Regulatory Strategies for Orphan Drugs Training Course

Regulatory Strategies for Orphan Drugs

29 Sep 2021

This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

4-5 Oct 2021

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Biosimilars Training Course

Biosimilars

5-6 Oct 2021

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

7-8 Oct 2021

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Pharmaceutical Development of ATMPs Training Course

Pharmaceutical Development of ATMPs

11-12 Oct 2021

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

Biosimilars Training Course

Biosimilars

12-13 Oct 2021

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

NEW EVENT!

Variations to Marketing Authorisations Training Course

Variations to Marketing Authorisations

14-15 Oct 2021

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

9-10 Nov 2021

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Development of Combination Products: Critical Interactions Training Course

Development of Combination Products: Critical Interactions

11-12 Nov 2021

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

Common Technical Document Training Course

Common Technical Document

29-30 Nov 2021

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

Common Technical Document Training Course

Common Technical Document

1-2 Dec 2021

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.