Phase I GMPs clinical trials

7 years ago Posted By : User Ref No: WURUR11590 0
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  • TypeWebinar
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  • Location Fresno, California, United States
  • Price
  • Date 16-05-2017
Phase I GMPs clinical trials, Fresno, California, United States
Webinar Title
Phase I GMPs clinical trials
Event Type
Webinar
Webinar Date
16-05-2017
Location
Fresno, California, United States
Organization Name / Organize By
Compliance4All
Organizing/Related Departments
Healthcare
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries

Education/Teaching/Training/Development

Manufacturing

Medical/Healthcare/Hospital

Location
Fresno, California, United States

Overview:

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Why should you Attend:

Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.

Areas Covered in the Session:

  • FDA regulations and Guidance Documents for Phase I clinical trials
  • Key elements and Best practices of GMP for Phase I clinical trials
  • IND content and format for CMC information
  • Vendor selection and management for outsourcing early manufacturing
  • Raw material selections and considerations

Who Will Benefit:

  • Directors
  • Managers/Supervisors
  • Regulatory Affairs
  • Manufacturing
  • Quality Assurance and Clinical Operations

 

Speaker Profile

Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).

She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Others Details

For more details and updates please visit webinar website

Registration Fees
Available
Registration Fees Details
One Dial-in One Attendee Price: $150.00 For more details and updates please visit webinar website
Registration Ways
Email
Phone
Website
Address/Venue
  Online  Pin/Zip Code : 94539
Official Email ID
Contact
Event Manager

Netzealous LLC DBA - Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: [email protected]

   Fax No: 302-288-6884