Tuesday, October 2, 2012; 1:00pm - 2:30pm EDT (GMT -4)
Are you exploring the possibilities of beginning drug or biologic clinical trials outside the U.S. or currently running these studies? The last several years have brought substantive changes in FDA regulations and priorities which affect the selection and oversight of overseas trials – including whether or not the FDA will even accept your foreign data in your approval submission. Are you taking FDA's expectations of how to conduct these clinical trials into account?
Traditionally, FDA regulations for foreign studies primarily addressed ethical requirements, but as international trials became more common, FDA developed more stringent requirements. In 2008 FDA announced strengthened 21 CFR 312.20 regulations for the use of data from drug and biologic trials conducted outside of the U.S. and intended to support U.S. submissions. Now, FDA is enforcing requirements for Good Clinical Practices, investigator training and the use of an Independent Ethics Committee.
These regulations are not going away. FDA has gained experience in applying these demanding rules to data intended for NDA, ANDA or BLA submissions. Inspections are becoming more rigorous as overseas FDA offices become more active and effective.
Clearly, it's vital you stay on top of how the foreign clinical study regulations are currently being applied – and how they could impact your own studies. Be sure you’re familiar with the provisions and pitfalls of the requirements now being emphasized for foreign clinical trials - join FOI Services and Dr. Joshua Sharlin for a 90-minute teleconference on Tuesday, October 2 beginning at 1:00pm EDT.
What You'll Learn:
- Why following just the ICH E6 and ICH E3 guidances will not meet all requirements of the regulations. (ICH - International Conference on Harmonisation; E6 - Good Clinical Practice; E3 - Structure and Content of Clinical Study Reports)
- FDA's definition of GCP for foreign clinical studies
- Roles and responsibilities of an Independent Ethics Committee
- How FDA will treat data from a non-compliant foreign study
- Regulations governing FDA's inspections of foreign clinical studies
- How to get a waiver for these requirements from FDA
- Impact of these regulations on compliance with local laws
- How to document requirements for investigator training
- Plus much, much more...
What You'll Get:
- A listing of the information required by FDA for a foreign clinical study to be in compliance
- An understanding of the rationale for the current regulations for foreign clinical studies
- An experienced and approachable instructor
- Time for questions and answers
Who Will Benefit:
Anyone responsible for the planning and execution of a foreign clinical trial or submission of an NDA, BLA or ANDA containing data from a foreign clinical trial, including:
- Trial monitors and staff
- Regulatory affairs
- Quality assurance/quality control personnel
- Anyone involved in the preparation of an FDA submission
About Your Presenter:
Joshua Sharlin, Ph.D., president of Sharlin Consulting, is a former FDA reviewer and has been consulting with FDA regulated drug, device and biologics companies for over 16 years. Nearly 50,000 people have attended his teleconferences addressing a wide range of technical and regulatory topics. His expertise includes software validation and Part 11 compliance, regulatory affairs, compliance, statistics, technical writing (SOPs, study reports, protocols and submission preparation) and developing strategies for approval. Dr. Sharlin brings an FDA reviewer’s perspective to your interactions with the agency, and you are invited to contact him about the content of any of his teleconferences and areas of expertise by calling +1-301-570-1107, emailing firstname.lastname@example.org or via his website.
How It Works:
Each toll-free (even if international) dial in is $449; put the teleconference on your speakerphone and have as many attendees as you like for this price. FOI Services will provide a handout 1-2 days before the teleconference. The materials may be duplicated for anyone attending.
Tuesday, October 2, 2012; 1:00pm-2:30pm EDT (GMT -4)
In your office or conference room