The enforcement environment for GMP and QSR matters has intensified. The consequences of non-compliance are significant ranging from facility shut downs, product application holds, consent decrees and criminal prosecutions. This webinar will provide focus to this enforcement environment and better prepare companies to address the range of global issues that arise. Regulatory, quality and global supply issues will be discussed.
| 10:00 – 10:10 a.m. |
Enforcement Environment --
Review of Significant Consequences |
Raymond Bonner |
| 10:10 – 10:25 a.m. |
GMP Enforcement Trends –
Major Issues |
Greer Lautrup,
Nathan Sheers |
| 10:25 – 10:40 a.m. |
Developing and Executing Corrective Action Plans |
Nathan Sheers,
Greer Lautrup |
| 10:40 – 10:55 a.m. |
International Enforcement –
Focus on Europe, China and India |
Maurits Lugard,
Lei Li,
Raymond Bonner |
| 10:55 – 11:10 a.m. |
World-Wide Coordination/Communication –
Regulatory, Quality, Legal re: Reporting Developments |
Raymond Bonner,
Maurits Lugard,
Lei Li |
| 11:10 – 11:20 a.m. |
Corporate and Individual Exposure –
Criminal, Civil – Including the False Claims Act |
Raymond Bonner |
| 11:20 – 11:30 a.m. |
Question and Answer |
|
This is a free webinar.
RSVP via email to
Sidley Austin LLP is an accredited MCLE provider in IL, NY and CA. CLE credit for this program is pending.
Sidley Austin’s Global Life Sciences Practice presents:
WHAT’S NEXT?
A series of presentations on emerging legal issues across the life sciences arena:
- Global Drug and Biotech Pricing: Risk and Rewards in an Evolving World Market
- Bridging the Value Gap: Options, Earnouts and other Alternative Structures for Life Science Transactions
- A New Era of GMP & QSR Enforcement – Emerging Trends and Issues
- A Small World: Evolving Tort Standards and Developments Around the Globe
- A Changing International Landscape: Patent Procurement and Enforcement