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Drug Development 101 Workshop Series

Workshop 4: Regulatory requirements & processes in drug discovery, development & approval



9 am – 12 pm, Nov. 19, 2016

Room 109, Robinson Hall, NEU

360 Huntington Ave, Boston, MA 02115


Audience: individuals who would like to gain a general understanding of the regulatory requirements and processes related to drug product development – from discovery to clinical, as well as product approval and lifecycle. The workshop will be focusing on the regulatory requirements in the US.


Presented by

Chinese-American BioMedical Association (CABA)

Department of Chemistry and Chemical Biology Biopharmaceutical Analysis Training Laboratory & Biotechnology Programs of NEU

Who Should Attend?

This workshop series is designed for biomedical professionals who want to learn patent law, technology transfer, licensing and regulatory strategies, specifically for those:

  • Working in a company who would like to understand why certain business decisions are made in product development or

  • Aspiring to start their own company

Sessions

  • Workshop 1: Interface of FDA Regulatory Framework & Patent Law

  • Workshop 2: Business Decisions Made in Product Development

  • Workshop 3: How to Commercialize Technologies

  • Workship 4: Regulatory requirements & processes in drug discovery, development & approval



For information about CABA and upcoming events, please check CABA Web site: www.cabaweb.org. 


Speakers

Dahua Pan, Ph.D.
Aegerion Pharmaceuticals, Regulatory Affairs Manager
Dr. Dahua Pan is a regulatory professional with 10 years of industry experience. He received his Ph.D in Medicinal Chemistry from University of Illinois at Chicago with research work focusing on computer-aided drug discovery. He has worked in several therapeutic areas and with multiple pharmaceutical products that are at various stages of the drug product life cycle - from early discovery to post-approval. He has broad regulatory experience in supporting global clinical trials, original NDA, FDA advisory meeting, postmarketing requirements, REMS and CMC supplements. Dr. Pan is currently regulatory affairs manager at Aegerion Pharmaceuticals Inc. in Cambridge MA.
Joy Wei, Ph.D. RAC
Shire, Global Regulatory Lead
Joy Wei, Ph.D, RAC is a global regulatory lead specialized in pharmaceutical product development in the US. Dr. Wei has over 10 years of regulatory affairs experience, involved in submission of initial FIH IND, NDA and BLA, developing global regulatory strategies, leading regulatory activities in preparation of pre-IND, pre-NDA meetings, and responding to Health Authority queries. Her experience at different stages of drug development ranging from products in clinical development (Phases I to IV) to approved products.

Date Time

2016-11-19 09:00 - Start

2016-11-19 12:00 - End

Ended
Address
  • 360 Huntington Ave , BOSTON  MA  02115

Registration

Type Sales End Price Quantity

Current CABA Members

2016-11-19 12:00 $75

Professionals, self-paying

2016-11-19 12:00 $100

Professional, company reimbursement

2016-11-19 12:00 $150

NEU Students

2016-11-19 12:00 $0

Sponsors & other Students

2016-11-19 12:00 $75

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