This Edition Sponsored by Kronos
Issue Highlights
- Picking Up Adverse Response Signals: Pharmacovigilance
- Reconsidering Retest Dates
- A Response to Russ Somma’s ISPE Talk
Pharmacovigilance: Extending QbD to the Post-Marketing Stage
QbD and continuous improvement should not stop at process scaleup. Data collection is critical, at each phase of a drug’s life cycle, and should feed into future development projects. Steve Jolley of PATNI discusses adverse events reporting and data collection with a view to continuous improvement.
Death to Retest Dates: How the QbD Sword May Strike Down this Trial Nemesis
Regulations by the EMEA and other global authorities that manufacturers post “Use By” dates on clinical trial products have long been the bane of clinical trial managers and budgeters. A mix of QbD, IT, and ISPE/PDA may soon slay the beast.
When is a CPP Not a CPP? Bikash Chatterjee Responds to Alistair Gillanders’ Blog
We had QbD Before the Term Was Even in Vogue: Malcolm Ross responds to ISPE Blog
Free Webcast: Long, Winding Road to Pharma QbD? FDA, Wyeth Weigh In
The webcast that launched a thousand ideas: “Pharmaceutical Quality by Design: The Road Ahead”, featuring Nasr and Winkle of FDA, Kowolenko and Simmons of Wyeth, and Avellanet of Cerulean Associates.
Best Practices in Manufacturing Drive the Adoption of Windows Vista
This informative webcast, presented by experts from Microsoft, Aberdeen and Iconics, will review next–generation software analytics solutions built on the latest open, scalable technologies. You’ll learn how to rapidly integrate new and existing systems into a unified management platform, resulting in enormous savings and improving the bottom line. Join us at 2 p.m. EST December 11, 2008. A question–and–answer period is included at the end of the presentation.
Stehlin Hopes to Maintain Better Control Over Phase I of Latest Oncology Candidate
Video: New Treatment for Lupus in Clinical Trials in New York
Metrics Completes 47,000-square-foot Contract Development Expansion
Education and Training Opportunities
Quality Expectations for Drugs and Biologics during Phase 3, and the NDA
When: November 13, 2008, 11:00 AM PDT/2:00 PM EDT
Are you fully cognizant of all quality-related activities involved in Phase 3 product clinical trials? Join this webcast to learn more about NDA requirements, and the necessary Phase 3 quality elements for CMCs. Key guidance documents are clarified, quality regulations illuminated, and working with the FDA through this process explained.
Coming Events
Drug Delivery to the Lungs Conference
Dec 10-12, Edinburgh
Contemporary Pharmacovigilance
Dec. 10-12, Singapore
Lab Automation 2009
Jan. 24-28, Palm Springs, Calif.
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