The Impact of FDAAA on Drug Safety
Horsham, PA (Vocus) May 27, 2008
The Drug Information Association's (DIA's) 44th Annual Meeting will feature more than 370 sessions and 30 tutorials focusing on issues affecting global drug discovery and development, including hot topic sessions on:
- Adaptive Clinical Designs/Adaptive Methods
- Approval Pathways for Products to Treat Rare Diseases
- Clinical and Regulatory Considerations for Personalized Medicines
- Combination Device and Therapeutic Products
- Critical Path Initiative
- Multinational Clinical Trials including Developing Countries
- Patient Recruitment and Retention
"Safety is always going to be a hot topic and with the FDA and EMEA both paying increased attention to the issue, it is especially so today," explains Annual Meeting Program Chair Jeffrey Sherman, MD, FACP.
This year's multi-track plenary session, "The Impact of FDAAA on Drug Safety," (Tuesday, June 24 from 8:00-9:30 am) will feature speakers from US and European regulatory agencies, the Reagan Udall Foundation, PhRMA, and other organizations to discuss their goals and experiences with implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Attendees can submit questions to the panel by Friday, June 20 to FDAAAondrugsafetypanel @ diahome.org; Subject: "Questions for the Panel."
The Venture Capital Roundtable: Biotechnology and Pharmaceutical/Health Care IT on Wednesday, June 25, will be of interest to many Boston-based companies, as will "A Device Primer: IDEs, 510(k)s, PMAs, and Beyond on Sunday, June 22. Also, the FDA Center for Drug Evaluation and Review (CDER) will hold its two-part Annual Town Hall-an interactive session where attendees can submit questions to senior CDER leaders--on Thursday, June 26.
As an international organization, global drug development is also a key focus of the Annual Meeting. This year's event will include more than 100 sessions on issues affecting key regions of the world, including:
- China - 18 sessions
- India - 12 sessions
- Japan - 23 sessions
- Taiwan - 4 sessions
- Vietnam - 1 session
- Latin America- 11 sessions
- Canada - 4 sessions
- Western Europe - 27 sessions
- Eastern Europe - 2 sessions
In addition, speakers from the following regulatory agencies will present at the Annual Meeting:
- ANMAT Ministry of Health (Argentina)
- ANMAT Ministry of Health (Brazil)
- Center for Drug Evaluation (Taiwan)
- EMEA (Europe)
- FDA MOPH (Thailand)
- Health Canada
- MHRA (UK)
- MHLW (Japan)
- Ministry of Health, Welfare and Sport (Netherlands)
- PMDA (Japan)
- SFDA (China)
- State Institute for Drug Control (Czech Republic)
- US FDA
- WHO (Switzerland)
For more information about the meeting, contact Joe Krasowski at 215-293-5812.
About the Drug Information Association (DIA)
The Drug Information Association serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, and Mumbai, India, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit http://www.diahome.org or call 215-442-6100.