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Orphan Drugs and Devices

 
  January 19, 2015  
     
 
CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
February 17, 2015 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This online training will benefit professionals in the pharmaceutical, biologic and medical device industries who are developing an orphan drug or device. Departments such as drug development, regulatory, medical affairs, clinical operations, manufacturing and research and development personal will be emphasized.

Course Description
This 90-minute accredited online training will supply an overview of orphan drugs and devices with emphasis on regulatory pathways and approval both in the US and EU. Emphasis on definitions, proper regulatory channels, documentation and marketplace analysis will be given to the attendees. FDA regulation 21 CFR 316.20 and EU regulation ENTR/8283/00 will be discussed.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Bart Chapman, MD, MBA and Fellow of the American Academy of Ophthalmology

As a board certified physician with over 30 successful years in the biopharmaceutical and medical device industry Bart Chapman MD MBA has been involved in approved NDAs, BLAs and PMAs and directing clinical trials through all phases.

His role has varied from developing Phase I-IV protocols and implementing them to overseeing strategic marketing and regulatory compliance. He has been involved in designing and implementing MOPS which have included integrating protocol design and phase I- IV implementation with the launch and marketing of approved products.

As both an employee as well as a consultant to numerous pharmaceutical companies from Fortune 100 companies to small biotech companies, Dr. Chapman has a successful track record in developing strategic plans. In the process he has designed and implement GLP and GMP facilities.

Dr. Chapman has secured sophisticated SABs as well as participated in numerous leadership roles as both physician investigator as well as physician advisor for the development of ocular, infectious disease, diabetes, oncology and medical device therapeutics.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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