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Preparation of FDA Submissions and Communicating with the FDA

  January 23, 2018  
CfPIE - The Center for Professional Innovation & Education, Boston, MA USA
October 31 & November 1, 2018

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

This course will give participants the necessary overview of the US Food and Drug Administration's (FDA) current responsibilities, procedures, guidances and regulatory pathways that affect the review and approval of chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics. Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed, as a basis for strategic planning for both submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements, as well as for holding key meetings with the FDA.

Similarities and differences between clinical INDs and market approval dossiers, and between the various market approval dossiers (NDAs, BLAs, and ANDAs) will be discussed. Other topics to be discussed include Fast Track pathway, comparison of chemical generics with biosimilars, FDA's commitments under the User Fee Acts (PDUFA, BsUFA, GDUFA) and FDA's evaluation of industry's performance in meeting its requirements and expectations for review of drug products.

Who Should Attend

Personnel in the pharmaceutical, biopharmaceutical, biologics and generic drug industry who are involved in preparing FDA submissions (INDs, NDAs, BLAs, ANDAs, post-approval supplements) will find this course to be of particular benefit. Those who need to interact with FDA staff, including Project Managers, Regulatory Affairs, Clinical, Nonclinical, Manufacturing, and Quality personnel, will also find this course extremely useful.

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

Albert Yehaskel

Albert Yehaskel

Specialties: Regulatory



Albert Yehaskel is an independent consultant with EAS Consulting Group, LLC, who has over 47 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.

Following 17 years of medicinal research, he subsequently entered the area of Regulatory Affairs, international and domestic, gaining valuable global regulatory experience. He has worked for Lederle Laboratories (American Cyanamid) now known as Wyeth, Block Drug, Sanofi, Purdue Pharma, Daiichi-Sankyo, Shionogi USA, Inc. and INDIGO Pharmaceuticals. He has devoted over 30 years to Regulatory Affairs, managing and directing domestic and international Regulatory Submissions, orchestrating key FDA meetings and conducting Pharmaceutical Research and development.

While at Sankyo, he filed and obtained approval of two electronic NDAs whose products (Benicar and Benicar/HCT) are currently on the market. He has also filed numerous IND applications, amendments, supplements, Special Protocol Amendments, Labeling and other Regulatory documents with FDA. Albert enjoys and likes the challenge of electronic submissions, both NDAs and INDs.  Albert also worked for Shionogi USA, a prominent, Osaka, Japan-based company, where he challenged himself to apply his Regulatory knowledge and knowledge of Japanese business.

Albert has interacted with over 13 different divisions at FDA (CDER, CBER, CDRH), orchestrating and participating in teleconferences and face-to-face meetings such as pre-IND, guidance meetings, EOP2 meetings, pre-NDA meetings and meetings with the Carcinogenicity Assessment Committee.

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.

Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=258
E-mail: info@cfpie.com
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