FDA’s Big Global Quality Harmonization Dilemma – Webinar Recording/Transcript
Are you ready for the coming global quality harmonization changes?
To the rescue: the FDA’s former top enforcement official prepares you with this presentation.
While the FDA had been pushing toward more global quality harmonization for decades, the pandemic put this into overdrive, as the agency focused on additional cooperation with foreign regulators.
Not to mention that lawmakers in the U.S. and beyond are focused on the risk created by global supply chains, as addressed in multiple provisions of the CARES Act.
With the UK and EU agreeing to the mutual recognition of inspections and certifications of medicines as part of a landmark Brexit-related trade deal, manufacturing facilities do not need to undergo separate UK and EU inspections.
Revisions went into effect on May 1 with the Pharmaceutical Inspection Co-operation Scheme (PICS) Good Manufacturing Practices Guide put together by an informal cooperative of 54 regulators around the world striving to develop common GMP standards in the industry. Its Annex 2A and Annex 2B are meant to enable harmonization with the European Commission.
Howard Sklamberg, a partner with Arnold & Porter and former FDA deputy commissioner for global regulatory operations and policy, will share how recent cooperation in inspections, regulator focus on global supply chains and other harmonization efforts will affect your company. You’ll understand how it will affect the expectations and behavior of regulators.
- The future of the U.S.-EU Mutual Recognition Agreement and what it means for inspections
- The long-lasting effects of FDA’s guidance on inspection alternatives during the pandemic — will these reforms continue?
- How the CARES Act provisions on the supply chain will affect harmonization and how companies should prepare
- The effect of pharmaceutical onshoring initiatives in the U.S. and Europe on harmonization efforts and what that means for manufacturers
- How to prepare for FDA’s ongoing quality metrics initiatives
Get ready for the coming global quality harmonization changes. This former top FDAer will help you keep up.
Meet Your Presenter
Howard Sklamberg, a partner with Arnold & Porter, counsels clients on a wide range of compliance and enforcement issues related to FDA regulation and policy. His experience is rooted in a deep understanding of U.S. and foreign food, drug and medical device law and policy, enabling him to guide domestic and international clients through the regulatory challenges they face. Areas of expertise include inspections and warning letters, investigations, civil and criminal enforcement, medical product applications and clinical research, food and hemp regulation, imports, the development of FDA policy and FDA-related legislation, and business transactions involving FDA-regulated companies.
Prior to entering private practice, Mr. Sklamberg held a variety of roles at the FDA from 2010 to 2017, including deputy commissioner for global regulatory operations and policy; director of the office of compliance, Center for Drug Evaluation and Research; deputy associate commissioner for regulatory affairs; and director in the Office of Enforcement. While at the agency, he directed an office of over 5,000 employees in more than 200 offices, laboratories and import facilities across the U.S., Asia, Europe and Latin America. As deputy commissioner, Mr. Sklamberg was FDA’s top enforcement official. He oversaw the agency’s inspections, enforcement, recalls and import operations programs.
Who Will Benefit
- QA/QC personnel
- R&D management
- Compliance officers
- Executive management
- Laboratory management
- Regulatory/legislative professionals
- Manufacturing directors and supervisors
- Validation specialists, scientists
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June 10, 2021