“Regulatory Brief on Medical Device & Pharmaceuticals Regulation in the US, EU and Israel in 2015 “
with Guest Speakers
Alan G. Minsk,
Arnall Golden Gregory Attorneys at Law (USA)
CEO & Founder of Physio-Logic Consulting (Israel)
Sponsored by Samuel – Burstein Accountants, Bio-Jerusalem, the JCT – Lev Academic Center and the Jerusalem Business Networking Forum – Biomed Division, and the participation of Physio-Logics Consulting.
Wednesday, November 26th, 2014 at 17:45
Alan G. Minsk, Arnall Golden Gregory Attorneys at Law (USA) , will be on a short visit to Israel at the end of November and has agreed to again address the JBNF-Biomed along with Gadi Ginot, CEO & Founder of Physio-Logic Consulting Services.
Alan G. Minsk and Gadi Ginot will be presenting some recent regulatory developments affecting regulation of medical devices in the U.S., E.U, and Israel and drug product in the U.S. Alan will give an overview of the latest FDA 510(k) guidance as well as on the “latest” regarding breakthrough therapy for drugs and on any “new” issues regarding orphan drugs. Gadi will give an overview on device regulation including IVDs ( In Vitro Diagnostics), both in Israel and in the EU and a brief on combination products (device-drug/biologics).
About our speakers:
Alan G. Minsk, Arnall Golden Gregory Attorneys at Law (USA)
Alan G. Minsk is a Partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP, located in Atlanta, Georgia and Washington, D.C. Prior to his association with AGG, he worked with a Washington, D.C. food and drug law firm. Mr. Minsk advises pharmaceutical, medical device, and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration, and certain matters concerning the U.S. Department of Agriculture, the Federal Trade Commission, the Drug Enforcement Administration, the Bureau of Alcohol, Tobacco and Firearms, and the Consumer Product Safety Commission. He counsels clients and has spoken and written on a wide variety of FDA-related issues, including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports. He serves on the Editorial Advisory Boards of the RAPS Focus magazine, the Center for Communication Compliance, and the Law Journal Newsletters’ Product Liability Law & Strategy journals and serves on the University of Georgia College of Pharmacy Regulatory Affairs Advisory Board.
Mr. Minsk was recently selected as Chambers USA: America’s Leading Lawyers in Life Sciences: Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers 2013 and 2014. Nominees are selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. He serves on the Board of GaBio, the PDMA Alliance (as the General Counsel), and the Atlanta Jewish Academy. He is the former Georgia Chapter Leader of the Regulatory Affairs Professionals Society, and is also a member of the Food and Drug Law Institute and the American-Israel Chamber of Commerce (Southeast Region–Medical Committee). He is a graduate of Brandeis University and Georgetown University Law Center.
For more information on Mr. Minsk, see: http://www.agg.com/Alan-Minsk/
Gadi Ginot, CEO & Founder of Physio-Logic Consulting (Israel)
Gadi Ginot (M.Sc, M.B.A) is the CEO & Founder of Physio-Logic Consulting – a one-stop shop for medical device and combination product quality assurance (QA), software QA, regulatory affairs (RA) and contract clinical research (CRO) solutions. Gadi has over 20 years’ experience in developing innovative QRC strategies that work. Gadi managed medical device & Combination product QA, RA and Clinical Research in global manufacturers as well as start-ups including scores of sponsored relocations to Europe and the US. Gadi has a track record of setting regulatory precedents in the US FDA, and EU markets, multiple scores of CE marking and ISO13485 certifications, and cost-effective global clinical development programs from first-in-man to post marketing clinical trials.
One-stop shop for QA, sQA, RA and Contract Clinical Resarch (CRO) solutions for medical device and combination products. Physio-Logic custom tailored consulting solutions range from off-site ad-hoc consultation, to contract integrated on-site solutions to turn-key solutions. Our experienced, multi-disciplinary team headed by Gadi Ginot enables clients to benefit from professional synergy and operational flexibility. Physio-Logic has a track record of successful, on-time and on-budget execution of global regulatory strategies including FDA submissions, post FDA inspection remediation programs, CE marking, AMAR registration, ISO 13485 certification, QMS and design V&V programs, and international first-in-man and pivotal clinical trials for all device classes. Physio-Logic serves the top global medical device manufacturers and Israel’s most reputable serial entrepreneurs and start-ups.