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International Society of Regulatory Toxicology and Pharmacology 2010 Endocrine Workshop EDSP Compliance

International Society of Regulatory Toxicology and Pharmacology 2010 Endocrine Workshop EDSP Compliance. December 13, 2010 Lister Hill Auditorium NLM, National Institutes of Health Bethesda, Maryland. Welcome. Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC 20006

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International Society of Regulatory Toxicology and Pharmacology 2010 Endocrine Workshop EDSP Compliance

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  1. International Society of Regulatory Toxicology and Pharmacology2010 Endocrine Workshop EDSP Compliance December 13, 2010 Lister Hill Auditorium NLM, National Institutes of Health Bethesda, Maryland Quill Law Group LLC

  2. Welcome Terry F. Quill Quill Law Group LLC 1667 K St, NW Washington, DC 20006 202-508-1075 www.QuillLaw.com Tquill@QuillLaw.com Quill Law Group LLC

  3. Workshop Planning Committee • Rick Becker • Chris Borgert • Sarah Brozena • Erik Janus • Terry Quill • Special thanks to Sallie Carr (ISRTP Executive Secretary) Quill Law Group LLC

  4. Co-Sponsors • American Chemistry Council • American Cleaning Institute • American Petroleum Institute • Chemical Producers and Distributors Association • Consumer Specialty Products Association • CropLife America • Endocrine Policy Forum • ExxonMobil Biomedical Sciences, Inc. Quill Law Group LLC

  5. Co-sponsors • Grocery Manufacturers Association • Personal Care Products Council • Polystyrene Packaging Council Inc. • Society of Chemical Manufacturers & Affiliates, Inc. • SOCMA VISIONS • Steptoe & Johnson • Synthetic Organic Chemical Manufacturers • Styrene Information and Research Center Quill Law Group LLC

  6. Exhibitors • ABC LABS • BATTELLE • BIOQUAL • HARLAN • RTI • STEPTOE & JOHNSON • WIL RESEARCH • WILDLIFE INTERNATONAL Quill Law Group LLC

  7. ANNOUNCEMENTS • Membership Opportunities • Availability of Proceedings • Future Workshops and Webinars • Spring Workshop • Fall Workshop • 2011 Webinars • Breaks, Lunch and Reception Quill Law Group LLC

  8. Workshop Goals - 1 • Provide an update on key issues related to responding to and complying with current EDSP test orders. • Session I: Challenges and Lessons Learned • Compliance, Timing. Procedural and Legal Issues • OSRI • Test Guidelines: Problems and Modifications • Who is affected? • Current Order Recipients • Phase 2 Order Recipients • Order Recipients in Future Phases Quill Law Group LLC

  9. Workshop Goals - 2 • Discuss EPA’s EDSP Phase 2 • EDSP Phase 2 Policies and Procedures, Chemical Listing, Information Collection Request • Preparing Comments • Responding to Orders: forming Consortia • Afternoon Session I: EDSP Phase II: Listing, Policies & Procedures, ICR • Who is affected? • Phase 2 Order Recipients • Order Recipients in Future Phases Quill Law Group LLC

  10. Workshop Goals - 3 • Future Challenges • Adverse event reporting • Weight of Evidence • Communications Issues • Afternoon Session II: Challenges Ahead • Who is affected? • Current Order Recipients • Phase 2 Order Recipients • Order Recipients in Future Phases Quill Law Group LLC

  11. Future Events • Webinars • Deeper drill on key EDSP issues • Every other month in 2011 • Specific topics TBD • ISRTP Member Rates • Spring Endocrine Workshop • Scope TBD • ISRTP Member Rates • Fall ISRTP Workshop • Topic TBD • ISRTP Member Rates Quill Law Group LLC

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