IVD PMAs

April 16, 2015

Pharma Development and Business

CfPA-The Center for Professional Advancement, New Brunswick, NJ
October 14-15, 2015

Who Should Attend?
This course is directed to:

Pharmaceutical personnel who are responsible for or interact with clinical and regulatory departments that develop Drugs, Biologics and IVDs
Medical and Regulatory Directors, Project Managers, Research Coordinators and Marketing personnel in new product development
Clinical Researchers and Regulatory personnel responsible for submitting INDs, NDAs, BLAs and IVD PMAs
Quality Assurance and Pharmacovigilance Departments Participants should have some knowledge of the pharmaceutical development process and/or intend to be involved in new product applications for FDA submissions

Course Description

The intricate components of IND, NDA, BLA and IVD PMA applications for FDA approvals will be detailed based on the requirements of the US code of Federal Regulations, ICH Guidelines and the agencies recommendations. These applications will be correlated with how to submit them in the CTD format (Modules 1-5). Each of these regulatory documents will be presented as they are related to safety, quality and efficacy. Details of preclinical/nonclinical data (pharm./tox) clinical data and CMC requirements for substance and product necessary to achieve new product approvals in the US and globally will be presented.

Other topics include:

FDAs internal structure, policies and procedures and meeting outcomes
Regulations and requirements for new product submissions (PDUFA, FDAAA, FDASIA, MDUFA and GDUFA)
Acceptance of international data for use in new product approvals in the US
Correlations of EU directives, FDAs Code of Federal Regulations and ICH guidelines

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

Richard A. Guarino, MD; President, Oxford Pharmaceutical Resources, Inc.

Richard A. Guarino MD, KM, is Chief Medical and Regulatory Director of Validus Pharmaceuticals LLC & President of Oxford Pharmaceutical Resources, Inc., a Consulting Clinical and Regulatory firm specializing in assessing clinical and regulatory requirements of INDs, NDAs, BLAs and PMAs. Dr, Guarino has 40 years of experience in investigational and new drug applications, marketing launches, pharmaceutical and product advertising, and FDA Liaison. The former President and CEO of Oxford Research International Corp. one of the largest CRO’s in the United States, Dr. Guarino serves as adjunct professor at Fairleigh Dickinson University. He has been Director of Clinical Research at Sandoz Pharmaceutical and VP/Medical Director with Revlon Healthcare. His acclaimed book, New Drug Approval Process, is the first written to help expedite the new drug approval process while following the requirements of the US, EU & ICH Guidelines.

Dr. Guarino is a member of the University Club (NYC), NJ & NY Academies of Medicine, Royal Society of Medicine, Columbus Citizens Foundation, Columbian Foundation, Presidential Advisory Cabinet at Fairleigh Dickinson University, Lupus Erythematosus Foundation, Cystic Fibrosis Foundation, Sovereign Military Hospitaller Order of Saint John of Jerusalem of Rhodes as a Knight of Malta, USA Drug Information Association, Association of Clinical Research Professionals and Academy of Pharmaceutical Physicians and Investigators.

Deadline for Abstracts:

n/a

Registration:

Please click here for registration information.

E-mail:

sberg@cfpa.com

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