Are you ready for the coming global quality harmonization changes?
To the rescue: the FDA’s former top enforcement official prepares you with this webinar.
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.
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