New Safety Reporting Requirements for Drugs and Biologics:Dissecting the FDA’s Sept. 29 Final Rule and Draft Guidance
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The FDA has given drugmakers a mere 5 months to comply with complex new drug and biologic safety reporting requirements.
But you can get up to speed in a hurry. Here’s how ...
In an effort to improve signal detection, the FDA issued a final rule and draft guidance on September 29 that requires drug and biologics sponsors to retool their worldwide adverse events reporting process in drug and biologic clinical trials.
The rule becomes effective March 28, 2011. With only five months to go, firms need to move quickly to rework SOPs, train investigators and staff, adapt trial protocols or designs and reprogram EDC systems in order to assure compliance.
It’s not much time, for sure. Think you can make it?
Well, here’s some much-needed help.
FDAnews has pulled out all the stops to create a must-attend compliance webinar covering the draft guidance and the FDA’s expectations, and has engaged two leading experts in pharmacovigilance, privacy and data protection:
- An internationally-recognized attorney who formerly headed data and privacy protection for Novartis’s global operations
- A former Hoffmann-La Roche executive who has participated in development projects with more than 50 clinical programs that led to successful INDs, NDAs and EMEA/CTA applications
SPECIAL BONUS AVAILABLE ONLY TO WEBINAR ATTENDEES
You’ll receive a PDF of Ms. Antokol’s and Dr. McLane’s marked up copy of the new rule, with their compliance tips and key sections highlighted. You can’t get this document anywhere else.
In 90 fast-paced minutes, Joan Antokol, Managing Partner at Park Legal, LLC and Dr. John McLane, COO and VP Clinical and Regulatory Affairs with Clinquest Inc., will analyze the final rule and guidance, advise how to manage individual safety events in various settings, and offer compliance tips for sponsors, CROs and investigators. You’ll discover:
- What you must do differently in terms of drug safety reporting, safety surveillance and monitoring
- New privacy measures you must put in place to be in compliance
- How U.S. privacy laws (HIPAA/HITECH/state laws), as well as laws of other countries where your products are under study, affect your new responsibilities
- How to get baseline incidence rates
- And much more!
Events that suggest a significant risk to study participants must be reported within 15 days of the sponsor becoming aware of such an occurrence, under the new rule. So, you’ll learn how to set up a systematic surveillance program to track and report such safety data, and how to periodically review and analyze safety databases to ensure proper reporting of adverse events associated with investigational drugs.
The New Safety Reporting Requirements for Drugs and Biologics webinar is convenient to attend. All that’s required is that you be in front of a computer monitor at the appointed time, whether you’re at the office or telecommuting from your office-in-home.
Of course, Ms. Antokol and Dr. McLane will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in safety reporting will benefit from taking part in this event — and they can do so at a cost that won’t break your budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.
The new rule takes effect March 28, 2011. You know you must prepare. So don’t wait another moment.