The Importance of Regulatory CMC Strategy

Events , News , News & Events
Wednesday 11 January 2023

Accelerate development using a Quality Target Product Profile

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Having the right Chemistry, Manufacturing, and Controls (CMC) documentation throughout drug development is essential for avoiding pitfalls, ensuring an efficient regulatory review process, and achieving the goals for your product. The key is an early development regulatory strategy that includes CMC.

Join our regulatory CMC webinar to strengthen your knowledge of how regulatory CMC strategies can accelerate the drug development process and become familiar with strategic tools such as the Quality Target Product Profile (QTPP).

Agenda

10:00 Start and introduction by Hilde Holme

Product Development by Hilde Holme

Quality Target Product Profile by Marianne Ammitzbøll

CMC Documentation & Roadmap by Hilde Foros and Lone Dyrby

Summary by Lone Dyrby

10:30 Q&A

10:45 End

Speaker bios:

Lone Dyrby,

Regulatory Director, Denmark
Lone.Dyrby[@]linkmedical.eu

Lone has 20 years of experience within Regulatory CMC for biologics from the pharmaceutical industry and from the Danish Medicines Agency. Lone has over 10 years of leadership experience.

Hilde Holme,

Regulatory Director, Norway
Hilde.Holme[@]linkmedical.eu

Hilde has 25 years of experience in the pharmaceutical industry within research, QC, QA, and regulatory affairs, working extensively within all aspects of regulatory CMC worldwide. Hilde has over 15 years of leadership experience

Marianne Ammitzbøll,

Senior Regulatory Manager
Marianne.ammitzboll@linkmedical.eu

Marianne has over 10 years of experience within Regulatory CMC in development and lifecycle projects from various positions in the pharmaceutical industry.

Hilde Foros,

Senior Regulatory Manager
Hilde.foros[@]linkmedical.eu

Hilde has more than 20 years of experience in the pharmaceutical industry within various technical roles and regulatory CMC responsibilities, including both pre-marketing and post-marketing CMC.

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The Importance of Regulatory CMC Strategy

Accelerate development using a Quality Target Product Profile

Agenda

Speaker bios:

Lone Dyrby,

Hilde Holme,

Marianne Ammitzbøll,

Hilde Foros,

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