Course Description: Regenerative medicine focuses on harnessing the power of ones own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administrations (FDA) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (HCT/Ps) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in the industry on how such therapies should be regulated by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.
This 2-day interactive seminar on FDA regulations of regenerative medicine will cover:
-How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use. -The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products. -The New Drug Application (NDA) and the Biologic License Application (BLA) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements. -The option for obtaining designation and approval as Orphan Drug Product. -Designing and conducting appropriate clinical trials to support the approval of regenerative therapies. -FDAs regulation of some regenerative medicine products and accessories as Medical Devices. -The Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) being applied by FDA to human regenerative products. -The labeling and marketing of regenerative products and therapies. -The potential for enforcement action and recommendations for mitigating that risk. -The current regulation of veterinary cellular treatments including autologous, allogeneic and xenogeneic cellular products in the United States.
Learning Objectives: Participants who attend this course on FDA regulation of regenerative medicines will leave with a comprehensive understanding of:
-How FDA regulates regenerative treatments and therapies? -The HCT/P Criteria and Minimal Manipulation Standard. -The Drug and Biological Approval Process. -Regenerative Products as Medical Devices. -How to Design Appropriate Clinical Trials? -Applicable cGMPs and cGLPs. -Marketing Exclusivity and Patent Restoration. -Product Labeling, Marketing and Advertising. -FDA and other Federal Agency Enforcement Action. -The Regulation of Veterinary Regenerative Medicine. -The New Animal Drug Application (NADA) Process. -Veterinary User Fees and Waivers.
Who will benefit: This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:
-Senior quality managers -Quality professionals -Regulatory professionals -Compliance professionals -Production supervisors -Manufacturing engineers -Production engineers -Design engineers -Labelers and Private Labelers -Contract Manufacturers -Importers and Custom Agents -U.S. Agents of Foreign Corporations -Process owners -Quality engineers -Quality auditors -Document control specialists -Record retention specialists -Medical affairs -Legal Professionals -Financial Advisors and Institutional Investors -Consultants, Inspectors and cGMP Experts
Read more:
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering, Etc.
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- Geron's Embryonic Stem Cell Clinical Trial for Spinal Cord Injury - September 15th, 2011 [September 15th, 2011]
- Hans Keirstead - Stem Cell Research Human Clinical Trials - September 15th, 2011 [September 15th, 2011]
- Stem-Cell Human Trials - September 15th, 2011 [September 15th, 2011]
- Geron: FDA Clearance for Human Clinical Stem Cell Trials - September 15th, 2011 [September 15th, 2011]
- Eric Legrand Rutgers University shout out, Listen up! - September 20th, 2011 [September 20th, 2011]
- How to Mend a Broken Heart - September 20th, 2011 [September 20th, 2011]
- Human Embryonic Stem Cell History! - September 20th, 2011 [September 20th, 2011]
- Robert Lanza - ACT - Stem cells and organ cloning interview - September 20th, 2011 [September 20th, 2011]
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- Diabetes: Spotlight on Stem Cell Research - Ed Baetge - September 23rd, 2011 [September 23rd, 2011]
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- Cardiovascular Therapies: Spotlight on Stem Cell Research - Yung-Wei Chi - September 24th, 2011 [September 24th, 2011]
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- StemCells Gains 5% on Neural Stem Cell Trial in Spinal Cord Injury - September 24th, 2011 [September 24th, 2011]
- Stem-Cell Research on Animals - September 24th, 2011 [September 24th, 2011]
- First hESC Therapy Clinical Trial - September 24th, 2011 [September 24th, 2011]
- Stem Cell Testing on Human Subjects [Officially] Begins • NBC Nightly News • October 11th, 2010 - September 24th, 2011 [September 24th, 2011]
- Leukemia: Spotlight on Stem Cell Research - Catriona Jamieson - September 24th, 2011 [September 24th, 2011]
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- Lou Gehrig's Disease (ALS): Progress and Promise in Stem Cell Research - September 25th, 2011 [September 25th, 2011]
- Hans Keirstead - September 25th, 2011 [September 25th, 2011]
- Stem Cell Quiz - September 25th, 2011 [September 25th, 2011]
- NZ Stemcell Trials - Part Two - September 25th, 2011 [September 25th, 2011]
- Drug Trials in a Dish - September 25th, 2011 [September 25th, 2011]
- Rise and Walk - September 25th, 2011 [September 25th, 2011]
- Catriona Jamieson: Therapies Based on Cancer Stem Cells - September 27th, 2011 [September 27th, 2011]
- Vatican lending hand in adult stem cell research - September 28th, 2011 [September 28th, 2011]
- Why STEM-Enhance? - September 28th, 2011 [September 28th, 2011]
- Genetic Underpinnings of Alopecia Areata - September 29th, 2011 [September 29th, 2011]
- Batten Disease: Spotlight on Stem Cell Research - Ann Tsukamoto - September 29th, 2011 [September 29th, 2011]
- stem cell trial for leading causes of blindness - October 9th, 2011 [October 9th, 2011]
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- Human Trials of Embryonic Stem Cell Treatment Beginning - Video - October 13th, 2011 [October 13th, 2011]
- Rise and Walk - Video - October 13th, 2011 [October 13th, 2011]
- Mesenchymal Stem Cell Trials - Video - October 14th, 2011 [October 14th, 2011]
- Spinal Cord Injury: Progress and Promise in Stem Cell Research - Video - October 14th, 2011 [October 14th, 2011]
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- MAJOR EMBRYONIC STEM CELL BREAKTHROUGHS - Video - October 22nd, 2011 [October 22nd, 2011]
- Batten Disease: Spotlight on Stem Cell Research - Stephen Huhn - Video - November 13th, 2011 [November 13th, 2011]
- Human Cloning has Begun | Playing God? - Video - November 15th, 2011 [November 15th, 2011]
- Diabetes: Advancing Stem Cell Therapies - 2011 CIRM Grantee Meeting - Video - November 15th, 2011 [November 15th, 2011]
- Brain Tumors: Advancing Stem Cell Therapies - 2011 CIRM Grantee Meeting - Video - November 15th, 2011 [November 15th, 2011]
- Double Blind Trial of Stem Cells for Heart Failure - Video - December 4th, 2011 [December 4th, 2011]
- Cardiac Stem Cell Therapy Clinical Trial - Video - December 4th, 2011 [December 4th, 2011]
- Glasgow Hospital Conducts First Stem Cell Trials on Stroke Patients - Video - December 4th, 2011 [December 4th, 2011]
- Dr Dietrich discusses the Geron stem cell trial to treat acute spinal cord injury - Video - December 4th, 2011 [December 4th, 2011]
- Stem Cell Research Today: Larry Goldstein - CIRM Science Writer's Seminar - Video - December 7th, 2011 [December 7th, 2011]
- Stem Cell Clinical Trial for Heart Failure: Eduardo Marban - CIRM Spotlight on Disease - Video - December 22nd, 2011 [December 22nd, 2011]
- Clinical trials and stem cells: what patients should consider - Video - January 2nd, 2012 [January 2nd, 2012]
- Spare Parts for Humans: Tissue Engineers Aim for Lab-Grown Limbs, Lungs and More - Video - January 4th, 2012 [January 4th, 2012]
- CIRM Grant Writing: RFA's - Where does your Project Fit? - Video - January 5th, 2012 [January 5th, 2012]
- Prometheus and I: building new body parts from stem cells (15 Nov 2011) - Video - January 5th, 2012 [January 5th, 2012]
- News Bulletin 18 November 2011 -- The Christian Institute - Video - January 5th, 2012 [January 5th, 2012]
- The Brain on Trial: How Neuroscience Challenges the Law as We Know It - Video - January 5th, 2012 [January 5th, 2012]
- The Human Genome and Individualized Medicine - David Valle, MD - Video - January 5th, 2012 [January 5th, 2012]
- 2010 Professional of Distinction - Discovery Awards - Video - January 23rd, 2012 [January 23rd, 2012]
- Research at The Nebraska Medical Center Biologics Production Facility - Video - January 24th, 2012 [January 24th, 2012]
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- StemCells, Inc. Announces Publication of Preclinical Data Demonstrating Its Human Neural Stem Cells Preserve Vision - January 31st, 2012 [January 31st, 2012]
- $30 million donation from Boris family will help McMaster turn stem cell research into therapy - February 6th, 2012 [February 6th, 2012]
- Stem Cell Treatment For Blindness Shows Promise In Trials - February 7th, 2012 [February 7th, 2012]
- ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from ... - February 13th, 2012 [February 13th, 2012]