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(September 21, 2009) Max Talbott: “What You Need to Know About the FDA from the Very Beginning of Your Company's Existence: Regulatory 101 for Startup Companies”
| What | |
|---|---|
| When |
September 21, 2009 01:00 PM
September 21, 2009 02:00 PM
September 21, 2009 from 01:00 pm to 02:00 pm |
| Where | Beth Robertson Auditorium (IMM) |
| Contact Name | Damian Walsh |
| Contact Email | damian.walsh@uth.tmc.edu |
| Contact Phone | 713-500-3768 |
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The Alliance for NanoHealth is proud to announce the next ANH Seminar on September 21, 2009. Max Talbott, Owner of Max Talbott, LLC will be featured as the event’s keynote speaker. You are cordially invited to attend this session and encouraged to participate in the networking reception. Admission is free and open to the Texas Medical Center Community and Regional Academic Institutions. ***Light refreshments will be provided on a first-come-first-serve basis***
After a 30 year career as a government official and pharmaceutical/biotechnology executive, in 2002, Max Talbott established MAX TALBOTT LLC for the purpose of healthcare industry consulting with special concentrations in regulatory affairs and business development. Since that time, Max has consulted with many companies ranging in size from small, start-up biotechs to multi-national pharmaceutical / biotechnology / medical device enterprises.
During his industrial career, Max participated in over 500 drug, biotech and device development programs. In his government service in FDA’s medical device organization, he managed the oversight of hundreds of clinical trials as well as supervised numerous FDA advisory committee meetings. While at FDA, Max was also one of the key participants in the creation and implementation of the 510k, IDE, and PMA regulations.
To take advantage of this experience, in creating MAX TALBOTT LLC, Max has established a global network of associate experts who support Max in his international consulting efforts. Through this network of experts, many who have worked for Max at one time in their careers, MAX TALBOTT LLC can deliver the personal support of Max’s counsel to all clients on each project as well as on-the-ground tactical and strategic support in the U.S., North, Central and South America, Eastern and Western Europe, India and Asia. The range of global healthcare product regulatory capabilities provided by MAX TALBOTT LLC extends from the preclinical, “pre-IND” stage through registration and into the post-marketing environment.
In addition to these regulatory capabilities, MAX TALBOTT LLC can also provide the following healthcare product business development and support services:
• Due Diligence
• Business / Product Evaluation
• Investment Evaluation and Referral
• Arbitration / Litigation Support
• Expert Witness Testimony
• Advisory Committee Expertise
• Labeling / Advertisement Review
• Reimbursement Counseling
• Pharmaco-Economic Services
• Pharmacovigilance Management
Max’s educational experience includes a doctoral degree from Rutgers in immunology and pharmacology. Additional career information and professional references are available upon request. A summary of Max’s industrial and government experience follows as does a partial list of the major global products that have been approved under his regulatory direction.