CMC Module in Regulatory Submissions

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

LEARNING OBJECTIVES

Gain an overview of the regulatory requirements for both small and large molecules

Learn the structure and content of the CMC sections of a regulatory submission

Discover how QbD can support you in preparing a regulatory submission

Analyse real-world examples to understand practical application and challenges

KEY TOPICS

Understanding the Key Aspects of the CTD Global Dossier

The Drug Substance Sections of a CTD

The Importance of a Good Product Development Approach for the CTD

TRAINER

Dr. Laura Buttafoco

Protea, CEO

Laura has extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements. This includes writing and revision of CMC regulatory documentation for the drug substance and drug product used in veterinary and human hormonal therapy, antibiotics, statins, vaccines and over-the-counter medications. Laura’s experience brings a unique combination of scientific background and effective communication skills that are well-matched with her international perspective and experience. She was responsible for the outsourcing of all analytical and processing activities related to the development, scale-up, tech transfers and validation of pharmaceutical products within multidisciplinary teams managing in DSM, Janssen and Disphar. Laura also has in-depth and direct experience in collaborating and managing CROs and CMOs in culturally diverse environments, mostly within Europe and Asia (especially India and China). She is certified as an independent ICH-GCO and GLP auditor in clinical trials.

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