Course "FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Palo Alto, CA, USA (PRWEB) February 10, 2017
ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies. The two day seminar led by Debra Webster and David Cummings will be held on March 2 and 3, 2017 in Boston, MA, then on July 13 and 14, 2017 in Irvine, CA and on October 19 and 20, 2017 in Newark, NJ.
This training workshop will provide a historical context for the use of stem cells in medicine, where the field has been and where it is going.
For more information or to register for the seminar, please click here.
Speaker Debra Webster is an ex-FDA official with over 25 years’ experience in drug development, focusing on nonclinical toxicology and proof-of-concept. Dr. Webster is responsible for nonclinical and regulatory consulting to guide products from pre-IND application interactions with the FDA to New Drug Application (NDA) and Biological License Application (BLA) approval.
David A. Cummings is a regulatory consultant with more than 24 years of experience with development and regulatory affairs of small molecule and biologic products. His biologic experience includes viral antigens, enzymes, monoclonal antibodies, gene therapy products and therapeutic proteins. Presently, he is a Director of Chemistry, Manufacturing and Controls (CMC), for Cardinal Health Regulatory Sciences.
This two-day workshop will host discussions on fundamentals of stem cells and on how the FDA regulates regenerative treatments and therapies. The various sessions will also address drug and biological approval process, applicable good manufacturing and good laboratory practices, and FDA and other federal agency enforcement action. In addition, the course will provide the various examples of FDA approved use of stem cells in medicine and what is needed for the field to progress.
Thursday, March 2, 2017 (8.30 AM- 4.30 PM) and Friday, March 3, 2017 (8.30 AM- 4.30 PM)
Thursday, July 13, 2017 (8.30 AM- 4.30 PM) and Friday, July 14, 2017 (8.30 AM- 4.30 PM)
Thursday, October 19, 2017 (8.30 AM- 4.30 PM) and Friday, October 20, 2017 (8.30 AM- 4.30 PM)
Location 1: Boston, MA
Location 2: Irvine, CA
Location 3: Newark, NJ
Registration Cost: $1,999.00 per registration
Early bird discounts: For discounts on early registrations, please click here.
Register by phone: Please call our customer service specialists at +1-888-717-2436 or email to customercare(at)complianceonline(dot)com
For more information on ComplianceOnline or to browse through our trainings, please visit our website.
ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 35,000 professionals from 9,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (http://www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations.
For more information please contact:
A Reuben Bernard
Associate Director - ComplianceOnline
2479 East Bayshore Road
Suite 200, Palo Alto, CA 94303
Phone - +1-650-238-9656 | +1-888-717-2436
Fax - 650-565-8542