Monday, October 28, Pre-Conference API Workshop (separate registration is required)

Transcription

1 Monday, October 28, Pre-Conference API Workshop (separate registration is required) 8:00 a.m. 8:30 a.m. Pre-Conference GPhA/FDA API Workshop Registration 8:30 a.m. 9:00 a.m. Welcome and Introduction Update on Changes to API Review in OGD David Skanchy, Ph.D. Supervisory Chemist, DMF Staff, 9:00 a.m. 10:30 a.m. Completeness Assessment Haitao Li, Ph.D. Wei Song, Ph. D. Chemistry Reviewer, DMF Staff, Office of Generic Drugs, CDER, FDA Huyi Zhang, Ph.D. 10:30 a.m. 10:45 a.m. 10:45 a.m. 11:15 a.m. Industry Perspective on Completeness Assessments Ed Vanderbeck Senior Vice President, ChemWerth Inc. 11:15 a.m. 11: 45 a.m. Project Management in the DMF Staff Kun Shen, Pharm.D. Project Manager, DMF Staff, 11:45 a.m. 1:15 p.m. Luncheon White Oak 1:15 p.m. 1:45 p.m. QbR for API s Session I: Updates and Revisions Carolyn Cohran, Ph.D. 1:45 p.m. 2:30 p.m. QbR for API s Session II: Updates and Revisions Deborah Johnson, Ph.D.

2 2:30 p.m. 3:00 p.m. QbR for API s Session III: Process Development Information Ramnarayan Randad, Ph.D. 3:00 p.m. 3:15 p.m. 3:15 p.m. 4:00 p.m. Industry Perspective on Process Development Information for APIs Ed Vanderbeck Senior Vice President, ChemWerth Inc. 4:00 p.m. 5:00 p.m. Round Table and Q&A Moderator: Richard Stec, Ph.D. Vice President, Global Regulatory Affairs, Perrigo Company Carolyn Cohran, Ph.D. Deborah Johnson, Ph.D. Haitao Li, Ph.D. Ramnarayan Randad, Ph.D. Kun Shen, Pharm.D. Project Manager, DMF Staff, David Skanchy, Ph.D. Supervisory Chemist, DMF Staff, Wei Song, Ph. D. Chemistry Reviewer, DMF Staff, Office of Generic Drugs, CDER, FDA Ed Vanderbeck Senior Vice President, ChemWerth Inc. Huyi Zhang, Ph.D. 5:00 p.m. Closing Remarks David Skanchy, Ph.D. Supervisory Chemist, DMF Staff, Huyi Zhang, Ph.D. 5:00 p.m. 6:30 p.m. Reception for Workshop Participants *Agenda Subject to Change

3 Monday, October 28, Pre-Conference USP User Forum (separate registration is required) 7:00 a.m. 8:00 a.m. Pre-Conference USP User Forum Registration 8:00 a.m. 9:10 a.m. USP Overview The Value of a USP Monograph Donna Kaye Wilson, M.Sc., Ph.D. Director, Standards Acquistion, U.S. Pharmacopeial Convention USP Publications Linda Guard Vice President, Publications, U.S. Pharmacopeial Convention USP Revision Process Holly Chang Senior National Account Manager, U.S. Pharmacopeial Convention USP Reference Standards Doreen McDonald Senior National Account Manager, U.S. Pharmacopeial Convention 9:10 a.m. 9:50 a.m. Compendial Updates General Chapters <232>/<233> Elemental Impurities Status Update Kahkashan Zaidi, Ph.D. Principal Scientific Liaison, U.S. Pharmacopeia Convention Monograph Modernization Behnam Davani, Ph.D. Director, Monograph Modernization, U.S. Pharmacopeia Convention 9:50 a.m. 10:10 a.m. 10:10 a.m. 10:50 a.m. Compendial Updates General Chapter <1086>/<476> Organic Impurities in Drug Substances and Drug Products General Chapter <191> Identification Tests Antonio Hernandez-Cardoso, Ph.D. Senior Scientific Liaison, U.S. Pharmacopeia Convention 10:50 a.m. 11:20 a.m. Q&A and Closing Remarks *Agenda Subject to Change

4 Monday, October 28, Pre-Conference Project Manager Workshop (separate registration is required) 11:30 a.m. 12:30 p.m. Pre-Conference Project Manager Workshop Registration 12:30 p.m. 1:30 p.m. Project Information Exchange - Industry Perspective Robert Pollock, M.S., R.Ph. Senior Advisor and Member of the Board, Lachman Consultant Services, Inc. 1:30 p.m. 2:00 p.m. 2:00 p.m. 5:00 p.m. Project Manager Information Exchange - FDA 1) Generic Drug User Fee Amendments of 2012 Overview CDR Thomas Hinchliffe, Pharm.D. Special Assistant to the Director, 2) Communications Between Industry and FDA CDR Sean Belouin, Pharm.D., R.Ph. Regulatory Project Manager, 3) Complete Response (CR) and Review Efficiency Enhancements LDCR Linda Park, Pharm.D. Chemistry Project Manager, 4) Generic Drug User Fee Amendments of 2012 Tier Amendments LT Christina Kirby Regulatory Project Manager, 5:00 p.m. Workshop concludes 5:00 p.m. 6:30 p.m. Reception for Workshop Participants 5:00 p.m. 7:00 p.m Fall Technical Conference Registration *Agenda Subject to Change

5 Tuesday, October 29, GPhA/FDA Fall Technical Conference - Day 1 7:00 a.m. 8:00 a.m Fall Technical Conference Registration - Grand Ballroom Foyer Networking Breakfast - Salon F-H 8:00 a.m. 8:15 a.m. Welcome and Introduction David Gaugh, R.Ph. Senior Vice President, Sciences & Regulatory Affairs, GPhA 8:15 a.m. 9:00 a.m. Keynote Address Janet Woodcock, M.D. Director, Center for Dug Evaluation and Research, FDA 9:00 a.m. 9:30 a.m. Updates on Quality Metrics Russ Wesdyk, M.S. Scientific Coordinator, Office of Planning and Informatics Center for Dug Evaluation and Research, FDA 9:30 a.m. 10:00 a.m. Updates on Quality Metrics - Industry Perspectives Dan Snider, Ph.D. Vice President Morgantown RD, Mylan Inc. 10:00 a.m. 10:30 a.m. - Grand Ballroom Foyer 10:30 a.m. 11:00 a.m. Compliance and Quality FDA Doug Stearn, J.D. Deputy Director for Policy and Analysis, Office of Compliance, FDA 11:00 a.m. 11:30 a.m. Compliance and Quality - Industry Perspectives Carmen Shepard, J.D. Senior VP, Global Policy and Regulatory, Mylan Pharmaceuticals Inc. Roy Sturgeon, Ph.D. President, Lachman Consultants Services, Inc. 11:30 a.m. 12:00 p.m. Compliance and Quality - Panel Discussion Moderator: Tony Amann, Ph.D. Executive Director, Regulatory and Medical Affairs, Roxane Laboratories Inc. Molly Rapp Vice President, Regulatory Affairs, Fresenius Kabi USA LLC Carmen Shepard, J.D. Senior VP, Global Policy and Regulatory Mylan Pharmaceuticals Dan Snider, Ph.D. Vice President Morgantown RD, Mylan Inc. Doug Stearn, J.D. Deputy Director for Policy and Analysis, Office of Compliance, FDA Roy Sturgeon, Ph.D. President, Lachman Consultants Services, Inc. Russ Wesdyk, M.S. Scientific Coordinator, Office of Planning and Informatics Center for Dug Evaluation and Research, FDA Plenary Session: Bioequivalence - Clinical Endpoint Studies 3:30 p.m. - 5:00 p.m. 12:00 p.m. 1:15 p.m. Fall Technical Conference Luncheon - Salon F-H / Overflow Downstairs USP Luncheon (must RSVP) - Brookside

6 1:15 p.m. 1:45 p.m. Generic Drug User Fee Program (GDUFA) Updates - FDA Keith Flanagan, J.D. Regulatory Counsel, Thomas Hinchliffe, Pharm.D. Special Assistant to the Director, Theresa Mullin, Ph.D. Director, Office of Strategic Programs, FDA Majnu Thomas Operations Research Analyst, Office of Planning and Informatics, FDA 1:45 p.m. 2:15 p.m. GDUFA Updates - Industry Perspectives Gordon Johnston, R.Ph., M.S. Principal, Gordon Johnston Regulatory Consultants, LLC Marcie McClintic, J.D. Vice President and Chief of Staff, Mylan Inc. Richard Stec, Ph.D. Vice President, Global Regulatory Affairs, Perrigo Company 2:15 p.m. 2:45 p.m. GDUFA Q&A Panel Session Moderator: Richard Stec, Ph.D. Vice President, Global Regulatory Affairs, Perrigo Company Thomas Hinchliffe, Pharm.D. Special Assistant to the Director, Gordon Johnston, R.Ph., M.S. Principal, Gordon Johnston Regulatory Consultants, LLC Marcie McClintic, J.D. Vice President and Chief of Staff, Mylan Inc. Theresa Mullin, Ph.D. Director, Office of Strategic Programs, FDA Majnu Thomas Operations Research Analyst, Office of Planning and Informatics, FDA 2:45 p.m. 3:15 p.m. Complex Drugs Rob Lionberger, Ph.D. Deputy Director of Science (Acting), 3:15 p.m. 3:30 p.m. - Grand Ballroom Foyer Plenary Session: Bioequivalence - Clinical Endpoint Studies 3:30 p.m. - 5:00 p.m. - Salon A-E Breakout Session: Updates Regarding the OGD Division of Microbiology and ANDA Sterility Assurance Review 3:30 p.m. - 5:00 p.m. - White Flint Amphitheater Moderator: Tony Amann, Ph.D. Executive Director, Regulatory and Medical Affairs, Roxane Laboratories Inc. Moderator: Molly Rapp Vice President, Regulatory Affairs Fresenius Kabi USA LLC 5:00 p.m. 7:00 p.m. Networking Reception Grand Ballroom Foyer Murray Ducharme, Pharm.D., FCCP, FCP President and CEO Learn and Confirm Inc. Lynne Ensor, Ph.D. Acting Division Director/Deputy Director Division of Microbiology 7:00 p.m. 9:30 p.m. Dinner and Entertainment Grand Ballroom John Peters, M.D. Director, Division of Clinical Review Dominique Kendrick, R.Ph., RAC Senior Director, Regulatory Affairs Sagent Pharmaceuticals, Inc.

7 Wednesday, October 30, GPhA/FDA Fall Technical Conference - Day 2 7:30 a.m. 8:30 a.m Fall Technical Conference Registration - Grand Ballroom Foyer Networking Breakfast - Salon F-H 8:30 a.m. 9:30 a.m. Filing Review - FDA Iain Margand, R.Ph. Regulatory Support Management Johnny Young, M.A.L.A Regulatory Health Project Manager 9:30 a.m. 10:00 a.m. Filing Review - Industry Perspective Robert Pollock, M.S., R.Ph. Senior Advisor and Member of the Board, Lachman Consultant Services, Inc. 10:00 a.m. 10:30a.m. Filing Review - Panel Discussion Moderator: David Gaugh, R.Ph. Senior Vice President, Sciences & Regulatory Affairs, GPhA Iain Margand, R.Ph. Regulatory Support Management Robert Pollock, M.S., R.Ph. Senior Advisor and Member of the Board, Lachman Consultant Services, Inc. Johnny Young, M.A.L.A Regulatory Health Project Manager 10:30 a.m. 11:00 a.m. 11:00 a.m. 11:45 a.m. Inactive Ingredients Update - FDA Robert Iser, M.S. Division Director Chemistry Division IV 11:45 a.m. 1:00 p.m. Luncheon 1:00 p.m. - 2:30 p.m. Stability Moderator: Marcy Macdonald, RAC Vice President Regulatory Affairs, Impax Laboratories Nick Cappuccino, Jr., Ph.D. Vice President Scientific Affairs, Dr. Reddy s Laboratories, Inc. Kiran Krishnan Vice President Regulatory Affairs, Apotex Corporation Suhas Patankar, Ph.D. Chemist, Susan Rosencrance, Ph.D. Deputy Director of Chemistry (Acting),

8 2:30 p.m. 3:00 p.m. 3:00 p.m. 3:45 p.m. Office of Generic Drugs Director s Update Kathleen Uhl, M.D. Office Director (Acting), 3:45 p.m. 4:30 p.m. Closing Remarks Moderator: David Gaugh, R.Ph. Senior Vice President, Sciences & Regulatory Affairs, GPhA Tony Amann, Ph.D. Executive Director, Regulatory and Medical Affairs, Roxane Laboratories Inc. Marcy Macdonald, RAC Vice President Regulatory Affairs, Impax Laboratories Richard Stec, Ph.D. Vice President, Global Regulatory Affairs, Perrigo Company 4:30 p.m. Conference Concludes