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Preparing the CMC Section for MAAs-IMPDs

  January 24, 2018  
CfPIE - The Center for Professional Innovation & Education, Berlin, Germany
19 & 20 November, 2018

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course includes an overview of the relevant guidelines and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of MAAs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, manufacturing and pharmaceutical development. It will also discuss the use of Drug Master Files (DMF), Certificates of Suitability (CEPs) and preparation of the CTD Quality Overall Summary (Module 2).

Who Should Attend

This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of an MAA, and for personnel who are not involved in CMC document preparation but want an overall understanding of what is involved for both the drug substance and drug product. Note that the course covers the requirements for synthetic, small molecules and does not address biologics.

Organized by: Center for Professional Innovation & Education
Invited Speakers:

Laura Millichamp

Specialties: Management, Regulatory

Laura Millichamp is responsible for the management of projects involving the development of Chemistry Manufacturing and Controls (CMC). She provides scientific, technical and regulatory expertise and is involved in reviewing and preparing regulatory pharmaceutical documents: CMC sections of IMPD/IND, briefing packages for Scientific Advice, variations, CTD module 3, and the Quality Overall Summary of MAAs.

A UK registered Pharmacist, Laura obtained a MPharm in Pharmacy at the University of Portsmouth, and a Ph.D. in Pharmaceutical Sciences from the University of Manchester, UK in the field of hydrogels for topical drug delivery.

Laura brings 8 years of experience in the Pharmaceutical Industry, including 7 years as a Pharmaceutical Assessor at the Medicines and Healthcare Regulatory Agency (MHRA) where she assessed a broad range of active substances and finished product types including sterile, oral and topical dosage forms and Orphan Drugs. In this role Laura gained extensive experience of all licensing procedure types (Centralised, Decentralised, National, Mutual Recognition, variations, CMDh referrals, recalls). She was an EMA Expert, providing regulatory and scientific advice on a European level, and presenting challenging applications at the UK Expert committees and CHMP discussion meetings. Laura has experience of assessing MAAs including Quality by Design (QbD), Real Time Release Testing (RTRT) and Rapid Microbial Methods (RMM).

Prior to joining VCLS, Laura held the position of Senior Consultant at PAREXEL International. She provided highly successful pre and post approval regulatory strategies, authored Scientific Advice briefing packages, IMPD and dossier sections including Post Approval Change Management Protocol, prepared ATC code applications, and conducted gap analysis. Laura has experience of collaborating with companies of all sizes, from start up to global, and at all stages of the drug development process.

Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=302
E-mail: info@cfpie.com
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