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  July 09, 2014  
CfPA-The Center for Professional Advancement, Burlingame, CA
November 19-20, 2014

Who Should Attend
This course is directed to personnel who are responsible or participate in:

  • New Pharmaceutical Product Development: Project 
    Managers, Research Coordinators
  • Preclinical and Clinical Researchers who submit INDs, 
    NDAs in CTD Format
  • Regulatory Affairs personnel responsible for submitting
    INDs and NDAs to FDA
  • Quality Assurance Departments
  • Marketing Division Personnel involved in New Drug
    Development Decision Making

Participants should have some knowledge of the pharmaceutical development process and/or intend to be involved in new product applications for US submissions to FDA.

RAPS - Regulatory Affairs Professional Society 
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

The content of this course is to present detailed components of INDs/NDAs, in the CTD format (Modules 1-5). These regulatory submissions will be based on the requirements of the US Code of Federal Regulations, and ICH guidelines. Each of these regulatory documents will be presented as they are related to safety, quality and efficacy. Details of preclinical data, clinical data, and CMC data necessary to achieve new product approvals in the US will be presented. Recommendations for expediting new product approvals will be correlated with the regulatory procedures used by FDA.

Other topics presented that will help participants understand the structure and bureaucratic demands will include:

  • FDAs internal structure, policies and procedures
  • Regulation and requirements for new product submissions
  • 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.

Dr. Richard A. Guarino is President of Oxford Pharmaceutical Resources, Inc., a Consulting Clinical and Regulatory Organization specializing in the planning, implementing and submitting INDs, NDAs, in the CTDs format. Dr, Guarino has 35 years of experience in new drug applications, marketing launches, pharmaceutical and product advertising, and FDA Liaison. He was formerly the President and CEO of Oxford Research International Corp. one of the largest CRO's in the United States. Besides serving as an adjunct professor at Fairleigh Dickinson University, he was a former Director of Clinical Research at Sandoz Pharmaceutical Inc, (Novartis) and held the position of Vice President/Medical Director at Revlon Healthcare Group. He has been acclaimed for his book, New Drug Approval Process, now in its 5th edition. It is the first book ever written to guide and recommend ways to expedite the new drug approval process while following all the requirements of the US Code of Federal Regulations, EU Directives and ICH Guidelines.

Dr. Guarino is a member of many professional societies and associations including the New Jersey and New York Academies of Medicine, The Royal Society of Medicine, the Columbus Citizens Foundation, the Presidential Advisory Cabinet at Fairleigh Dickinson University, the Lupus Erythematosus Foundation, the Cystic Fibrosis Foundation and the Sovereign Military Hospitaller Order of Saint John of Jerusalem of Rhodes and of Malta American Association, USA Drug Information Association (DIA), Association of Clinical Research Professionals (ACRP), and Academy of Pharmaceutical Physicians and Investigators (APPI).
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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