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CMC Module in Regulatory Submissions
CMC
Pharma & Biotech

CMC Module in Regulatory Submissions

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

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

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

Learning Objective

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

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

Learning Objective

Discover how QbD can support you in preparing a regulatory submission

Discover how QbD can support you in preparing a regulatory submission

Learning Objective

Analyse real-world examples to understand practical application and challenges

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
The Drug Product CTD Sections
How to Ensure a Smooth Review of the Dossier?

TRAINER

Dr. Laura Buttafoco

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.

Learn More →