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OC LIFe (Lifesciences Innovators Forum) – COVID-19: Changes in FDA Approval & Clearance Processes
August 26, 2020 @ 3:00 pm - 4:30 pm
The OC LIFe (Life Science Innovators Forum) is a monthly free event series focused on creating a collaborative environment that fosters connections between innovators in the life sciences and medtech industry.
OCRA supports the OCLife FREE event August 16th: REGISTER
Changes in the FDA approval & clearance processes resulting from the COVID-19 pandemic.
On June 1, 2020, FDA Commissioner Stephen Hahn, MD announced “I have instructed my staff to identify the lessons learned from this [COVID-19] pandemic and what adjustments may be needed, not just to manage this or future emergencies, but to make FDA itself more efficient in carrying out our regulatory responsibilities.” Regulatory expert Piet Lesage will moderate a panel discussing the changes at the FDA so far, and what changes are likely to come in future FDA processes and regulation.
Piet is an International Business Development Expert, with over 20 years executive experience developing Global Strategies, and implementing International Business Development Plans.
Throughout his career, he helped start-ups and Fortune 500 companies develop their Global footprint:
- Setting up international distribution channels and partnerships
- Building and motivating country and regional subsidiaries to support one or more product lines
- Making organizational changes and implementing process change to support the international strategy
- Acquiring, integrating and managing overseas organizations to support the company’s global strategies
As a Principal Consultant at GB5D, he focuses on working with MedTech companies. Especially those SME’s that want to enter foreign markets and need to align their regulatory and reimbursement strategies.
Allison Komiyama is a former FDA reviewer who started AcKnowledge Regulatory Strategies in order to serve clients who manufacture implantable and other patient-contacting medical devices. She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. She received her Regulatory Affairs Certification (US) in 2014.
While working at FDA as a biologist and reviewer in the Office of Device Evaluation, Allison was a lead reviewer and consult on 510(k) Premarket Notifications, Pre-Submissions, Investigational Device Exemption (IDE) applications and Premarket approval (PMA) submissions. Her specialty was in biocompatibility requirements for implanted devices. She also researched neurotoxicity and systemic toxicity of medical devices in the Office of Science and Engineering Labs (OSEL) in support of FDA recognized ISO and ASTM standards. After her time at FDA, Allison worked as a project manager and regulatory affairs manager at an in vitro diagnostic device company, as well as a senior regulatory specialist and director of regulatory affairs at two consulting firms.
Allison has worked with clients from all around the world whose companies range from small two-person startups to large firms with over 40,000 employees. She has worked on a diverse range of devices, including orthopedic devices (spine, hip, knee, and other skeletal implants), bone void fillers, general hospital devices, urological devices, in vitro diagnostic devices, wearable technology, combination products, mobile medical applications and neuro-stimulating devices.
Shep Bentley, owner of Bentley Biomedical Consulting, is a regulatory affairs expert with proven experience at achieving domestic and international market approvals for innovative devices applying equally innovative approaches to regulators. His ability to pursue the least burdensome approach by the use of unique expressions of risk has met with success at the FDA and outside the U.S. With 32 years in the medical device industry and a wealth of knowledge and understanding of the letter and intent of federal regulations, he has built a solid reputation within the U.S. Department of Health & Human Services. Within the past ten years, Shep has extended his experience to the markets of the Australia, Brazil, Canada, China and the European Union. He maintains competitive relationships for his regulatory efforts. Within the past year, Shep has been featured as a keynote speaker and regulatory expert in conferences and symposia in the United States and Europe. His passion is to enable the best in medical technology to reach the public in the shortest time.Shep’s past clients as a regulatory consultant for device and drug regulatory strategies in U.S., Europe, Canada, Brazil, China, and Australia include numerous firms such as Abbott Labs, Alcon, Amgen, Baxter, Cardinal Health, Covidien, Edwards Lifesciences, Johnson & Johnson, Medtronic, St. Jude, and Valeant.Shep holds the rank of U.S. Marine Corps Lieutenant Colonel (ret.) and served in both Iraq wars.
He earned his Bachelor of Arts in Philology (International Literature) and advanced his studies at the Johannes Gutenberg University in Mainz/Germany. His professional affiliations include RAPS and TOPRA.
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