Best Practices in CMC Dossier Preparation – Facing Tough Challenges

Date: April 24, 2017
Time: RECORDED SESSION
Duration: 90 Minutes - Online
Price: $299 - Includes Bonus Handouts!

Course Description:

Global chemistry, manufacturing, and control (CMC) dossiers are critical to a successful regulatory submission.  The creation and subsequent assembly of the CMC dossier requires an orchestrated cooperation between R&D, clinical, regulatory, sales/marketing, and other groups who will have an input into this important document.  Managing the construction of a clear, concise dossier can be a daunting task, but it doesn’t have to be.  A simple understanding of best practices surrounding the creation and presentation of the CMC section will make for a successful submission…as long as your data is accurate and compelling!

This course will give the attendee the ability to create teams and divide labor/concepts that include:

  • Modular design of information
  • Work teams
  • Style guides
  • Educational programs
  • Project planning
  • Living in the “electronic environment”
  • Structured review of dossiers

Additionally, this course will cover some of the following challenges:

  1. Preparing a detailed and comprehensive NDA TOC (specifically Module 3 [DS and DP])
  2. Getting organized
  3. Reviewing what documents you have and which are missing
  4. Identifying rate limiting documents, e.g., stability reports-when will stability data be available
  5. On time  completion of registration batches-when available and when is stability
  6. Vetting with FDA any data that will be submitted late-creating a strategy
  7. Ensure manufacturing site is ready for inspection before submitting the NDA (goes on the 356h)-all reports and validation on file
  8. Interactive/structured review of all documents prepared
  9. Proper versioning of documents
  10. Finalizing documents ready for publishing

 

This course will be of benefit to anyone involved in the CMC section of a regulatory submission to the FDA.  This includes, but is not limited to:

  • technical and managerial staffs
  • project planning
  • regulatory affairs
  • manufacturing
  • marketing
  • quality assurance
  • information management

Albert Yehaskel is an independent consultant who has over 45 years of experience in the Pharmaceutical industry.  He is an experienced and accomplished pharmaceutical professional with a distinguished record of achievement and success in the management of regulatory affairs.

He has worked for Lederle Laboratories (American Cyanamid) as an international CMC regulator and, Block Drug, Sanofi, Purdue Pharma, Daiichi-Sankyo, Shionogi USA, Inc. and INDIGO Pharmaceuticals from pre-IND to post-NDA holding high level regulatory positons from senior director to VP positions.  In 2010, Albert began to consult, where his expertise encompasses drugs, biologics and medical devices. His early career was devoted to medicinal pharmaceutical research and development in the areas of antibiotics and CNS agents.

During his regulatory career he authored, managed and directed all types of domestic and international regulatory submissions. Albert has filed and obtained approval of two electronic NDAs whose products are currently on the market. He is also well versed in the area of eCTD, having written many CMC sections in Modules 2 and 3. He has also filed numerous IND applications, amendments, supplements, Special Protocol Amendments, Labeling and other Regulatory documents with FDA.

Albert has had direct experience with over 14 different divisions at FDA (CDER, CBER, CDRH), preparing briefing documents, engaging in preparatory rehearsals and subsequently orchestrating key FDA meeting. He has successfully negotiated with FDA in the areas of stability, labeling and the Carcinogenicity Assessment Committee (CAC).

Albert has built, managed and mentored regulatory teams as well as creating regulatory and quality infrastructures in companies that did not have any. He has written many SOPs and provided in-house training.

Albert earned two Master degrees; a Master of Business degree in Economics and Finance from Fairleigh Dickinson University and a Master of Science degree in Organic Chemistry from Queens College, City University of New York.  His Bachelor of Science degree in Chemistry was earned at the Polytechnic Institute of Brooklyn. He also served as an undergraduate instructor while pursuing his Master of Science degree, most recently taught several Regulatory Affairs modules at Stony Brook and teaches a CMC course for DIA on an annual basis.