Fall Technical Conference

Transcription

1 Bethesda North Marriott Hotel and Conference Center North Bethesda, MD November 2-4, Fall Technical Conference Monday, November 2, 2015 USP Workshop (separate registration required) 7:00 a.m. - 8:20 a.m. Pre-Conference USP Workshop Registration 8:30 a.m. 8:40 a.m. Welcome and Intro Emily Kaine, M.D. Vice President, Strategy and Business Development, U.S. Pharmacopeial Convention 8:40 a.m. - 9:15 a.m. USP Transition to the Cycle Mario P. Sindaco, M.S., M.B.A. Director, Compendial Affairs and Executive Secretariat, Council of Experts U.S. Pharmacopeial Convention o CoE and ECs o Resolutions overview o Stakeholder resources o Recent and upcoming general stakeholder interactions o Pending Monograph program 9:15 a.m. - 9:30 a.m. USP Science in : Elemental Impurities Implementation Update Mario P. Sindaco, M.S., M.B.A. Director, Compendial Affairs and Executive Secretariat, Council of Experts U.S. Pharmacopeial Convention 9:30 a.m. - 10:00 a.m. Reference Standards Evaluation Overview Steve Rau Manager, Reference Standards Evaluation, U.S. Pharmacopeial Convention 10:00 a.m. - 10:15 a.m. Networking Refreshment Break 10:15 a.m. - 10:40 a.m. USP-NF Up-to-Date Overview and Stakeholder Involvement Leonel M. Santos, Ph.D. Director, Chemical Medicines, U.S. Pharmacopeial Convention 10:40 a.m. - 11:05 a.m. USP Strategy: USP-NF Excipient Specifications Up-to-Date by 2020 Catherine M. Sheehan, M.S. Senior Director, Excipients & PDG, U.S. Pharmacopeial Convention 11:05 a.m. - 11:30 a.m. Current Approaches to Standards for Biologics and Biosimilars Tina S. Morris, Ph.D. Global Leader, Biological Standards, U.S. Pharmacopeial Convention 11:30 a.m. USP Workshop Concludes

2 Monday, November 2, GPhA Fall Technical Conference - Day 1 7:00 a.m. 5:00 p.m Fall Technical Conference Registration - Grand Ballroom Foyer 11:30 a.m. 1:00 p.m. Networking Welcome Lunch - Lower Level 1:00 p.m. 1:15 p.m. Welcome and Introduction David Gaugh, R.Ph. Senior Vice President, Sciences & Regulatory Affairs, GPhA 1:15 p.m. 2:00 p.m. Office of Generic Drugs Update Kathleen Uhl, M.D. Director, Office of Generic Drugs, CDER, FDA 2:00 p.m. 2:45 p.m. Office of Pharmaceutical Quality Update Lawrence Yu, Ph.D. Deputy Director, Office of Pharmaceutical Quality, CDER, FDA 2:45 p.m. 3:30 p.m. Networking Refreshment Break - Grand Ballroom Foyer 3:30 p.m. 4:30 p.m. DSCSA: Beyond Implementation Moderator: Eric Marshall Senior Director, Leavitt Partners Collaborative Advocates Mary Anne Anderson Director, Regulatory Affairs, Sagent Pharmaceuticals Mark Gutmann Senior Director Global Serialization Program, Mylan Inc. Brian Rezach Partner, OmniMedia Associates LLC Mary Woods Executive Director, US Order Management, Allergan 4:30 p.m. 5:30 p.m. Biosimilars Council - Key Issues Bruce Leicher, J.D. Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc. Peter Sullivan, Pharm.D. Director of Professional Affairs and Medical Information, Amneal Biosciences 5:30 p.m. 7:00 p.m. Networking Welcome Reception - Grand Ballroom Foyer

3 Tuesday, November 3, GPhA Fall Technical Conference - Day 2 7:00 a.m. 8:30 a.m Fall Technical Conference Registration - Grand Ballroom Foyer Networking Breakfast - Lower Level 8:30 a.m. 8:45 a.m. Welcome and Introduction David Gaugh, R.Ph. Senior Vice President, Sciences & Regulatory Affairs, GPhA 8:45 a.m. 9:00 a.m. State of the Association Chester Chip Davis, Jr. President and CEO, GPhA 9:00 a.m. 10:30 a.m. Pharmacovigilance Moderator: Gordon Johnston, R.Ph., M.S. Principal, Gordon Johnston Regulatory Consultants LLC Joan Janulis, RAC Vice President and Regulatory Affairs Practice Head, Lachman Consultants Services, Inc. Mark Vieder, R.Ph., MBA Director, Safety and Medical Writing, Biorasi 10:30 a.m. 11:00 a.m. Networking Refreshment Break - Grand Ballroom Foyer 11:00 a.m. 12:00 p.m. OPQs Integrated Quality Assessment Overview Susan Rosencrance, Ph.D. Office Director (Acting), Office of Lifecycle Drug Products, OPQ, CDER, FDA Benefits and Challenges from the Regulatory Business Process Manager Hany Edward, Pharm.D., M.S. Branch Chief (Acting), Regulatory Business Process Management II, Branch III OPRO, OPQ, CDER, FDA Benefits and Challenges from the Application Technical Lead Pahala Simamora, Ph.D. Branch Chief (Acting), Division of Liquid-based Drug Products, Office of Lifecycle Drug Products OPQ, CDER, FDA Additional Panelist: Robert Iser, M.S. Office Director (Acting), Office of Process and Facilities, OPQ, CDER, FDA Ann Marie Montemurro Supervisory Consumer Safety Officer, Office of Global Regulatory Operations and Policy ORA, CDER, FDA 12:00 p.m. 1:15 p.m. Fall Technical Conference Luncheon - Lower Level 1:15 p.m. 2:30 p.m. How an ANDA Gets Approved - Steps and Processes LCDR Kevin Denny, Pharm.D., Leader, Division of Project Manager, Office of Regulatory Operations, CDR Craig Kiester, R.Ph., M.S., RAC Branch Chief (Acting), Branch II, Office of Program and Regulatory Operations, OPQ, CDER, FDA 2:30 p.m. 3:00 p.m. Networking Refreshment Break - Grand Ballroom Foyer

4 Tuesday, November 3, GPhA Fall Technical Conference - Day 2 ICH Q12- Industry Perspective 3:00 p.m. - 4:00 p.m. - Salon A-E Project Manager Exposition (Interactive Session) 3:00 p.m. - 6:00 p.m. - White Oak Moderator: Keith Webber, Ph.D. Head of Regulatory Review, Regulatory Affairs Perrigo Company Nicholas Cappuccino, Jr., Ph.D. Vice President and Head of Global Quality Dr. Reddy s Laboratories Ltd. Dawn Culp Vice President, Global Regulatory Affairs Policy, Mylan Inc. 505 (b)(2) 4:00 p.m. - 5:00 p.m. - Salon A-E Drug Product Selection ANDA Review and Approval Office of Generic Drugs Product Launch Preparation OPQ RBPMs - Who We Are Moderator: Gordon Johnston, R.Ph., M.S. Principal, Gordon Johnston Regulatory Consultants LLC David Rosen, J.D. Partner, Foley & Lardner LLP Kenneth Phelps President and CEO, Camargo Pharmaceutical Services OM s Division of User Fee Management and Budget Formulation Entrance GPhA Entrance OPQ RBPMs - What s New in OPQ Industry Booths: Drug Product Selection - Selection of a Drug Product and following it thru the R&D process. ANDA Review and Approval - How Industry Manages the ANDA Review and Approvals Process. Product Launch Preparation - How Industry Prepares for an On Time Product Launch. GPhA Learn more about our trade association: Membership, Regulatory Affairs, State and Federal Affairs, Biosimilars Council, Meetings, and more. FDA Booths: Office of Generic Drugs - Organizational Chart - Roles and Responsibilities (including when to contact) Office of Pharmaceutical Quality RBPMs - Who We Are - Organizational Chart - Who s the Point of Contact - Roles and Responsibilities Office of Pharmaceutical Quality RBPMs - What s New in OPQ - Highlight New Processes - Then and Now - When to Contact OPQ RBPMs - Highlight the new Learning & Professional Development (LPD) and Organizational Excellence (OE ) branches Office of Management s Division of User Fee Management and Budget Formulation - When to Contact OM - How to Contact OM - Helpful Tips for Industry - Address Areas of Concerns Related to GDUFA User Fees

5 Tuesday, November 3, GPhA Fall Technical Conference - Day 2 Project Manager Exposition 3:00 p.m. - 6:00 p.m. - White Oak Participants: CAPT Trellis Adams, MSHS, BSN, WCC, CPHM, Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA Thushi Amini, Ph.D., Associate Director for Regulatory Affairs (Acting), Office of Research and Standards, Kris Andre, M.S., Senior Regulatory Project Manager, Office of Research and Standards, Thanh Andrews, M.A., BS, Special Assistant, Office of Regulatory Operations, Lloyd Ballou, Division Director, Organizational Excellence and Learning and Professional Development, OPRO, OPQ, CDER, FDA Surjit Basi, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, Michael Bohling, Director Marketing, Apotex Corp. CDR Tessa Brown, DHSc, MPH, BSN, RN, Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, Michael Brzica, Senior Director of Federal Affairs, GPhA LT Yen Anh Bui, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, Tanya Clayton, Division Director (Acting), Acting Branch Chief, Regulatory Business and Process Management Branch I, OPRO, OPQ, CDER, FDA Tramara Dam, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, Mary Dempsey, Associate Director for Regulatory Affairs, Immediate Office, LCDR Benjamin Y. Danso, Pharm.D., Branch Chief (Acting), Regulatory Business and Process Management Branch II/Branch IV, OPRO, CDER, FDA LCDR Kevin Denny, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, CDR Dat Doan, Pharm.D., Supervisory Project Manager, Division of Project Manager, Office of Regulatory Operations, Simon Eng, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA CDR Bob Gaines, Pharm.D., Division Director, Division of Regulatory and Business Process Management II, OPRO, OPQ, CDER, FDA Valerie Gallagher, Senior Director, Consumer Healthcare Regulatory Affairs, Perrigo Company TJ Garrigan, Associate Director, Policy and Strategic Alliances, GPhA CAPT. Lillie D. Golson, MSA, Pharm.D., Deputy Director (Acting), Division of Labeling Review, Office of Regulatory Operations Madhuri Gupta, Manager, Regulatory Affairs, Aveva Drug Delivery Systems Mark Hendrickson, Director, Sciences & Regulatory Affairs, GPhA Lyndsay Hennessey, PMP, Team Leader, Division of Project Manager, Office of Regulatory Operations, Missy Henry, Director, Regulatory Affairs, Sandoz Inc. LCDR Kevin Herkenham, Pharm.D., BCPP, Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, CDR Thomas Hinchliffe, Pharm.D., Regulatory Affairs Coordinator, Immediate Office, OGD CDER, FDA Evelyn Hong, Pharm.D., Program Manager, Applications Team Lead in the Generics Branch, Division of User Fee Management and Budget Formulation, OM, CDER, FDA Jasmeet (Mona) Kalsi, Pharm.D., Special Assistant, Office of Regulatory Operations, Savan Khanna, Pharm.D., Regulatory Business Project Manager, OPRO, OPQ, CDER, FDA LCDR Andrew Kim, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, Edward Kim M.P.A., M.P.H., Regulatory Affairs Coordinator, Immediate Office, OGD CDER, FDA Sonni Kim, Pharm.D., Branch Chief (Acting), Branch I, OPRO, OPQ, CDER, FDA Dawn Kimble-Vance, R.Ph., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, LCDR Jessica Kreger, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations Kiran Krishnan, Vice President, Regulatory Affairs, Apotex Corporation LT Mandy Kwong, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, Hongly La, Pharm.D., Regulatory Business Project Manager, OPRO, OPQ, CDER, FDA Erin Lee, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, Heidi Lee, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, Carrie Lemley, Project Manager, Division of Labeling Review, Office of Regulatory Operations, Dianoda Lewis, MBA, Management Analyst, Facility Team in the Generics Branch, Division of User Fee Management and Budget Formulation, OM, CDER, FDA LCDR Chitra Mahadevan, Pharm.D., Senior Supervisory Regulatory Officer, Office of Bioequivalence, LCDR Nimmy Mathews, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations Tania Mazza, Pharm.D., Regulatory Business Project Manager, OPRO, OPQ, CDER, FDA Denise Toyer McKan, Division Director, Division of Project Manager, Office of Regulatory Operations, Laurie Mohler, R.Ph., CGP, FASCP, Project Manager, Division of Filing Review, Office of Regulatory Operations, Eileen Monaghan, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA

6 Tuesday, November 3, GPhA Fall Technical Conference - Day 2 Project Manager Exposition 3:00 p.m. - 6:00 p.m. - White Oak Participants: LCDR Filita Moore, RN, Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA Gwendolyn Murphy, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, Victor Ng, Management Analyst, Applications Team Lead in the Generics Branch, Division of User Fee Management and Budget Formulation, OM, CDER, FDA LCDR Bic Nguyen, Pharm.D., BCPS, Team Leader, Division of Project Manager, Office of Regulatory Operations, Jennifer Nguyen, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA CDR Tina Nhu, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, Uzoma Nnebe, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, Linda O'Dea, Executive Director, Regulatory Affairs, Sandoz Inc. Gbenga Okubadejo, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA Marie Angeline O Shea, RN, MBA, Associate Director for Science and Communications (Acting), OPRO, OPQ, CDER, FDA CAPT Nitin Patel, Pharm.D., Senior BPM, Division of Clinical Review, Office of Bioequivalence, Gisa Perez, MBA, Generics Branch Chief, Division of User Fee Management and Budget Formulation, OM, CDER, FDA Hanah Pham, Pharm.D., Program Manager, Facilities Team Lead in the Generics Branch, Division of User Fee Management and Budget Formulation, OM, CDER, FDA Tiffany Pokora, Pharm.D., Project Manager Team Lead (Acting), Division of Bioequivalence II, Office of Bioequivalence, LCDR Susan E. Polifko, Pharm.D., Project Manager Team Lead (Acting), Division of Filing Review, Office of Regulatory Operations Catherine Poole, MS, Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, LCDR Andrew Potter, Pharm.D., BCPP, Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations LT Ryan Presto, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, Giuseppe Randazzo, M.S., Office Director (Acting), OPRO, OPQ, CDER, FDA Carlene Randolph, BSN, MBA, Associate Director of Regulatory Affairs (Acting), Office of Regulatory Operations, OGD CDER, FDA Peter Rickman, MA, Associate Director of Regulatory Affairs (Acting), Office of Regulatory Operations, Jorge Rondon, Organizational Excellence Branch Chief, Division III (Acting), OPRO,OPQ, CDER, FDA Rhonda Rowell R.Ph., Project Manager, Division of Filing Review, Office of Regulatory Operations, LCDR Danielle E. Russell, Pharm.D., Project Manager, Division of Labeling Review, Office of Regulatory Operations, CDR Vince Sansone, Pharm.D., Supervisory Project Manager, Division of Project Manager, Office of Regulatory Operations, CDR Leigh Ann Sears. MAHS, BSN, Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA Priya Shah, Pharm.D., Team Leader, Division of Project Manager, Office of Regulatory Operations, Edward Sherwood, BS, Director (Acting), Office of Regulatory Operations, CAPT. Aaron Sigler, Pharm.D., BCPS, Deputy Division Director, Division of Project Manager, Office of Regulatory Operations, Manina Singh, Pharm.D., Project Manager, Division of Bioequivalence III, Office of Bioequivalence, LCDR Chad Snuggerud, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations, LCDR Diana Solana-Sodeinde Pharm.D., Senior Supervisory Project Manager (Acting), Office of Bioequivalence, Lisa Tan, R.Ph, Associate Vice President, Sciences & Regulatory Affairs, GPhA Nicholas Tantillo, Head, Policy and Regulatory Strategy, Sandoz Inc. Edward (Andrew) Taylor, Pharm.D., Regulatory Project Manager, Division of Project Manager, Office of Regulatory Operations Margarita Tossa M.S., Senior BPM Lead (Acting), Division of Clinical Review, Office of Bioequivalence, Meghal Vakil, Project Leader, Regulatory Affairs, Apotex Corp. Heidi Wilson, Director of Federal Government Affairs, GPhA Lucie Yang, M.D., Ph.D., MBA, Division Director (Acting), Division of Quality Management Systems, Office of Regulatory Operations Steven Yang, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA LCDR Martin Yoon, Pharm.D., Senior BPM Lead (Acting), Division of Bioequivalence I, Office of Bioequivalence, Ankara Nicole (Nikki) Yokum, Pharm.D., Regulatory Business Process Manager, OPRO, OPQ, CDER, FDA 6:00 p.m. 7:30 p.m. Networking Reception Grand Ballroom Foyer 7:30 p.m. 10:00 p.m. 70 s Disco Dinner Party and Entertainment Salon A-E

7 Wednesday, November 4, GPhA Fall Technical Conference - Day 3 7:00 a.m. 8:30 a.m Fall Technical Conference Registration - Grand Ballroom Foyer Networking Breakfast - Lower Level Restricted Access Programs and Its Impact on ANDAs and Patient Access 8:30 a.m. - 9:30 a.m. - Salon A-D Moderator: Marcy Macdonald, RAC Vice President, Regulatory Affairs, Impax Laboratories Nicholas Tantillo Head, Policy and Regulatory Strategy, Sandoz Inc. Drug Substance Review in OPQ/ONDP and API Forum Introduction 8:30 a.m. - 8:50 a.m. - API Forum - Salon E-F Scott Furness, Ph.D. Deputy Director, ONDP, OPQ, CDER, FDA GDUFA Update/Completeness Assessments 8:50 a.m. - 9:20 a.m. - API Forum - Salon E-F Jayani Perera, Ph.D. Review Chemist, Division of Lifecycle API ONDP, OPQ, CDER, FDA GDUFA Regulatory Science Update & Bioequivalence Guidances 9:30 a.m. - 10:30 a.m. - Salon A-D Moderator: Scott Tomsky Vice President, Generic Regulatory Affairs, North America Teva Pharmaceuticals Robert Lionberger, Ph.D. Director, Office of Research and Standards Larissa Lapteva, M.D., M.H.S. Director (Acting), Division of Therapeutic Performance Office of Research and Standards, Networking Refreshment Break 10:30 a.m. - 11:00 a.m. Grand Ballroom Foyer Project Management for DMF Review in OPQ 9:20 a.m. - 9:50 a.m. - API Forum - Salon E-F Truong Quach, Pharm.D. Business Process Manager - Lifecycle API, OPRO OPQ, CDER, FDA Selected DMF Topics from the CDER DMF Expert 9:50 a.m. - 10:30a.m. - API Forum - Salon E-F Arthur Shaw, Ph.D. Review Chemist/DMF Expert, Division of New Drug Products II, ONDP, OPQ, CDER, FDA IID Update - Next Steps 11:00 a.m. - 12:00 p.m. - Salon A-D Moderator: Kiran Krishnan Vice President, Regulatory Affairs, Apotex Corporation David Schoneker Director, Global Regulatory Affairs, Colorcon, Inc. Priscilla Zawislak Global Regulatory Affairs Manager, Ashland Inc. Electronic DMF Submissions/New Guidance 11:00 a.m. - 11:30 a.m. - API Forum - Salon E-F Ginny Hussong Director, Division of Data Management Service and Solutions, OBI, CDER, FDA Starting Material Selection for Type II Drug Master Files 11:30 a.m. - 12:00 p.m. - API Forum - Salon E-F Ronald Michalak, Ph.D. Quality Assessment Lead (Acting), Division of Lifecycle API, ONDP, OPQ, CDER, FDA

8 Wednesday, November 4, GPhA Fall Technical Conference - Day 3 Dissolution - Biopharmaceutics Vision in Office of New Drug Products 12:00 p.m. - 12:30 p.m. - Salon A-D Open Panel Discussion 12:00 p.m. - 12:30 p.m. - API Forum - Salon E-H Moderator: Marcy Macdonald, RAC Vice President, Regulatory Affairs, Impax Laboratories Paul Seo, Ph.D. Division Director (Acting), Division of Biopharmaceutics Office of New Drug Products, OPQ, CDER, FDA GDUFA s Impact on ectds / Case Study: Implementing PDF Standards 1:45 p.m. - 2:45 p.m. - Salon A-D Fall Technical Conference Luncheon 12:30 p.m. - 1:45 p.m. Lower Level Moderator: Kiran Krishnan Vice President, Regulatory Affairs, Apotex Corporation Meghan Hughes Associate Director, Submission Ready Standards Program Lead, Teva Pharmaceuticals Kevin Tompkins Director, Head of North America Global Regulatory Operations, Teva Pharmaceuticals Moderator: Neeru Takiar Quality Assessment Lead, Division of Lifecycle API ONDP, OPQ, CDER, FDA All Morning FDA Speakers: Scott Furness, Ph.D. Ginny Hussong Ronald Michalak, Ph.D. Jayani Perera, Ph.D. Truong Quach, Pharm.D. Arthur Shaw, Ph.D. Risk Based Review for Drug Substance 1:45 p.m. - 2:15 p.m. - API Forum - Salon E-H Deborah Johnson, Ph.D. Branch Chief, Life Cycle Branch I, ONDP, OPQ, CDER, FDA ICH M7 Guidance 2:15 p.m. - 2:45 p.m. - API Forum - Salon E-H Stephen Miller, Ph.D. CMC Lead, ONDP, OPQ, CDER, FDA Bioequivalence Inspections: An Update from the Office of Study Integrity and Surveillance 2:45 p.m. - 3:45 p.m. - Salon A-D Moderator: Scott Tomsky Vice President, Generic Regulatory Affairs, North America Teva Pharmaceuticals John Kadavil, Ph.D. Pharmacologist, Office of Study Integrity and Surveillance Office of Translational Sciences, CDER, FDA Carmen Shepard, J.D. Senior Vice President, Global Policy & Regulatory Counsel, Mylan Inc. ICH M7 Impact on DMF Review 2:45 p.m. - 3:15 p.m. - API Forum - Salon E-H David Green Review Chemist and Quality Assessment Lead (Acting) Division of Lifecycle API, ONDP, OPQ, CDER, FDA Use of QSAR to Evaluate PGIs 3:15 p.m. - 3:45 p.m. - API Forum - Salon E-H Naomi Kruhlak, Ph.D. Lead, Chemical Informatics Program, Division of Applied Regulatory Sciences, OCP, OTS, CDER, FDA

9 Wednesday, November 4, GPhA Fall Technical Conference - Day 3 Current Trends in Labeling and Best Practices 3:45 p.m. - 4:30 p.m. - Salon A-D Moderator: Marcy Macdonald, RAC Vice President, Regulatory Affairs, Impax Laboratories CAPT. Lillie D. Golson, MSA, Pharm.D. Deputy Director (Acting), Division of Labeling Review Office of Regulatory Operations, AMES Data Submissions and Other Qualification Data for Impurities in DS 3:45 p.m. - 4:15 p.m. - API Forum - Salon E-H Mark Powley Pharmacologist, ONDP, CDER, FDA Open Panel Discussion 4:15 p.m. - 4:30 p.m. - API Forum - Salon E-H Moderator: Barbara Scott Drug Substance Reviewer, Division of Lifecycle API ONDP, OPQ, CDER, FDA All Afternoon FDA Speakers: David Green Deborah Johnson, Ph.D. Naomi Kruhlak, Ph.D. Stephen Miller, Ph.D. Mark Powley Closing Remarks 4:30 p.m. - 4:35 p.m. - Salon A-D David Gaugh, R.Ph. Senior Vice President, Sciences & Regulatory Affairs, GPhA Closing Remarks 4:30 p.m. - 4:35 p.m. - API Forum - Salon E-H Richard Stec, Ph.D. Vice President, Global Regulatory Affairs Perrigo Company Conference Concludes 4:35 p.m.