FDA Law Blog: International Pharmaceutical and Medical Device Supply Chains Imperiled Like Never Before - A Webinar Presented by Dechert LLP and HP&M

FDA Law Blog: International Pharmaceutical and Medical Device Supply Chains Imperiled Like Never Before - A Webinar Presented by Dechert LLP and HP&M

International Pharmaceutical and Medical Device Supply Chains Imperiled Like Never Before - A Webinar Presented by Dechert LLP and HP&M

Posted: 02 Sep 2016 11:42 AM PDT

 

In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. Furthermore, increased enforcement aimed at the medical device industry and the safety and effectiveness of medical device production have become a key focus of global regulators.

With the latest updates to the global standard for medical device quality management systems and the proposed new EU Medical Device Regulations, device manufacturers, service providers, and supply chain partners will need to closely assess their product lifecycle risk management systems to ensure they are complying with requirements.

This webinar will discuss these recent pharmaceutical and medical device supply chain developments and what steps companies need to take to prevent and remediate compliance issues in the context of:

• The uptick in investigations in China and India.
• Speed vs. Safety: the approval process differences between the EU and U.S.
• Increased scrutiny of non-EU-based manufactures and requirements for importers and distributors.
• The potential impact of adverse regulatory actions against nonconforming facilities.
• Threats posed by bribery and corruption.
• Anti-corruption compliance issues from U.S. and Asian perspectives.
• “War stories” from recent investigations.

When

Wednesday, September 14, 2016
1:30 p.m. - 2:30 p.m. BST (8:30 a.m. - 9:30 a.m. EDT)

A recording of the webinar will be available to all registrants after the live event.

Where

This presentation will be simulcast via Webex as a webinar.  Please click here to register.

Speakers

Douglas B. Farquhar
Director
Hyman, Phelps & McNamara PC
Washington, D.C.

Mark I. Schwartz
Of Counsel
Hyman, Phelps & McNamara PC
Washington, D.C.

Jeremy B. Zucker 
Partner
Dechert LLP
Washington, D.C.

Lewis Ho
Partner
Dechert LLP
Hong Kong

Kareena Teh
Partner
Dechert LLP
Hong Kong

Sophie Pelé
Associate
Dechert LLP
Paris

Application for accreditation of this program for Continuing Professional Development (CPD) in the United Kingdom is currently pending.  Application for accreditation of this program for Continuing Legal Education (CLE) in California, Massachusetts, New Jersey, and New York is currently pending.

For questions, please contact Reiko Tate (reiko.tate@dechert.com).