FDAnews Announces FDA’s Big Global Quality Harmonization Dilemma: Can the Agency Reconcile ICH, PICS & Domestic Manufacturing Initiatives During a Pandemic? Webinar

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Ready for the coming global quality harmonization changes? Former top FDA enforcement official prepares attendees. Register now.

WCG FDAnews

WCG FDAnews

FDA’s Big Global Quality Harmonization Dilemma:
Can the Agency Reconcile ICH, PICS & Domestic Manufacturing Initiatives During a Pandemic?
An FDAnews Webinar
Thursday, June 10, 2021, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/fdas-big-global-quality-harmonization-dilemma

The pharmaceutical quality landscape is changing with global harmonization. Will you be able to keep up? The FDA’s former top enforcement official prepares attendees 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.

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 the company. Attendees will understand how it will affect the expectations and behavior of regulators, explaining:

  • 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.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
FDA’s Big Global Quality Harmonization Dilemma:
Can the Agency Reconcile ICH, PICS & Domestic Manufacturing Initiatives During a Pandemic?
An FDAnews Webinar
Thursday, June 10, 2021, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/fdas-big-global-quality-harmonization-dilemma

Tuition:
$287 per site

Easy Ways to Register:
Online: https://wcg.swoogo.com/fdas-big-global-quality-harmonization-dilemma
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
FDAnews
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