Protecting the Pharma Supply Chain: FDA Efforts at Global Harmonization
Protect your company from stumbling on new harmonization efforts by the FDA and regulators across the globe looking to shore up the supply chain.
The pandemic may have underscored supply chain fragilities but there are no signs regulators are letting up.
Protecting the Pharma Supply Chain: FDA Efforts at Global Harmonization explains the changes so you can pivot accordingly and comply with stricter quality standards, new supply chain rules and enhanced quality manufacturing metrics.
This report explains what stricter quality standards in places, such as India and China, means for those outsourcing there, the latest legislation and executive orders that create new supply chain rules for essential drugs, the FDA’s possible push for the assignment of public-facing letter grades for manufacturing facilities and much more.
While harmonizing good manufacturing practice (GMP) regulations across borders and instituting more information-sharing between U.S. regulators and others will prevent the kinds of drug shortages and reduced quality brought about by the pandemic, it means additional burdens on pharmaceutical companies.
Based on a webinar by Howard Sklamberg, partner at Arnold & Porter and former FDA deputy commissioner for global regulatory operations and policy, Protecting the Pharma Supply Chain explains:
- The future of the U.S.-EU Mutual Recognition Agreement and what it means for inspections
- The long-lasting effects of FDA 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 the FDA’s ongoing quality metrics initiative
About the Contributor
Howard Sklamberg, a partner with Arnold & Porter and the former top enforcement official for the FDA, 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.
Who Will Benefit
- Quality management leaders
- Regulatory personnel
- Legal affairs personnel
- Supply-chain personnel
- Receiving personnel
- Purchasing personnel
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