Monday, October 28, 20132013 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 Sta�, O�ce of Generic Drugs, FDA

9:00 a.m. – 10:30 a.m. Completeness Assessment Haitao Li, Ph.D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA Wei Song, Ph. D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, CDER, FDA Huyi Zhang, Ph.D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA 10:30 a.m. – 10:45 a.m. Networking Refreshment Break

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 Sta� Kun Shen, Pharm.D. Project Manager, DMF Sta�, O�ce of Generic Drugs, FDA

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. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA 1:45 p.m. – 2:30 p.m. QbR for API’s Session II: Updates and Revisions Deborah Johnson, Ph.D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA

2:30 p.m. – 3:00 p.m. QbR for API’s Session III: Process Development Information Ramnarayan Randad, Ph.D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA

3:00 p.m. – 3:15 p.m. Networking Refreshment Break

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 A�airs, Perrigo Company Carolyn Cohran, Ph.D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA Deborah Johnson, Ph.D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA Haitao Li, Ph.D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA Ramnarayan Randad, Ph.D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA Kun Shen, Pharm.D. Project Manager, DMF Sta�, O�ce of Generic Drugs, FDA David Skanchy, Ph.D. Supervisory Chemist, DMF Sta�, O�ce of Generic Drugs, FDA Wei Song, Ph. D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, CDER, FDA Ed Vanderbeck Senior Vice President, ChemWerth Inc. Huyi Zhang, Ph.D. Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA

5:00 p.m. Closing Remarks David Skanchy, Ph.D. Supervisory Chemist, DMF Sta�, O�ce of Generic Drugs, FDA Huyi Zhang, Ph.D.

Chemistry Reviewer, DMF Sta�, O�ce of Generic Drugs, FDA

5:00 p.m. – 6:30 p.m. Reception for Workshop Participants

*Agenda Subject to Change

Monday, October 28, 20132013 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 Scienti�c 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. Networking Refreshment Break

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 Scienti�c Liaison, U.S. Pharmacopeia Convention

10:50 a.m. – 11:20 a.m. Q&A and Closing Remarks

*Agenda Subject to Change

Monday, October 28, 20132013 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. Networking Refreshment Break

2:00 p.m. – 5:00 p.m. Project Manager Information Exchange - FDA 1) Generic Drug User Fee Amendments of 2012 Overview CDR Thomas Hinchli�e, Pharm.D. Special Assistant to the Director, O�ce of Generic Drugs, FDA 2) Communications Between Industry and FDA CDR Sean Belouin, Pharm.D., R.Ph. Regulatory Project Manager, O�ce of Generic Drugs, FDA 3) Complete Response (CR) and Review E�ciency Enhancements LDCR Linda Park, Pharm.D. Chemistry Project Manager, O�ce of Generic Drugs, FDA 4) Generic Drug User Fee Amendments of 2012 Tier Amendments LT Christina Kirby Regulatory Project Manager, O�ce of Generic Drugs, FDA 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. 2013 Fall Technical Conference Registration

*Agenda Subject to Change

Tuesday, October 29, 20132013 GPhA/FDA Fall Technical Conference - Day 1

7:00 a.m. – 8:00 a.m. 2013 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 A�airs, 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. Scienti�c Coordinator, O�ce 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. Networking Refreshment Break - 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, O�ce 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 A�airs, Roxane Laboratories Inc. Molly Rapp Vice President, Regulatory A�airs, 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, O�ce of Compliance, FDA Roy Sturgeon, Ph.D. President, Lachman Consultants Services, Inc. Russ Wesdyk, M.S. Scienti�c Coordinator, O�ce of Planning and Informatics Center for Dug Evaluation and Research, FDA

12:00 p.m. – 1:15 p.m. Fall Technical Conference Luncheon - Salon F-H / Over�ow Downstairs USP Luncheon (must RSVP) - Brookside

Plenary Session:Bioequivalence - ClinicalEndpoint Studies3:30 p.m. - 5:00 p.m.

1:15 p.m. – 1:45 p.m. Generic Drug User Fee Program (GDUFA) Updates - FDA Keith Flanagan, J.D. Regulatory Counsel, O�ce of Generic Drugs, FDA Thomas Hinchli�e, Pharm.D. Special Assistant to the Director, O�ce of Generic Drugs, FDA Theresa Mullin, Ph.D. Director, O�ce of Strategic Programs, FDA Majnu Thomas Operations Research Analyst, O�ce 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 Sta�, Mylan Inc. Richard Stec, Ph.D. Vice President, Global Regulatory A�airs, Perrigo Company 2:15 p.m. – 2:45 p.m. GDUFA – Q&A Panel Session Moderator: Richard Stec, Ph.D. Vice President, Global Regulatory A�airs, Perrigo Company Thomas Hinchli�e, Pharm.D. Special Assistant to the Director, O�ce of Generic Drugs, FDA Gordon Johnston, R.Ph., M.S. Principal, Gordon Johnston Regulatory Consultants, LLC Marcie McClintic, J.D. Vice President and Chief of Sta�, Mylan Inc. Theresa Mullin, Ph.D. Director, O�ce of Strategic Programs, FDA Majnu Thomas Operations Research Analyst, O�ce of Planning and Informatics, FDA

2:45 p.m. – 3:15 p.m. Complex Drugs Rob Lionberger, Ph.D. Deputy Director of Science (Acting), O�ce of Generic Drugs, FDA 3:15 p.m. – 3:30 p.m. Networking Refreshment Break - Grand Ballroom Foyer

Plenary Session:Bioequivalence - ClinicalEndpoint Studies3:30 p.m. - 5:00 p.m. - Salon A-E

Breakout Session:Updates Regarding the OGD Division of Microbiology and ANDA Sterility Assurance Review3:30 p.m. - 5:00 p.m. - White Flint Amphitheater

Moderator: Tony Amann, Ph.D.Executive Director, Regulatory and Medical A�airs, Roxane Laboratories Inc.

Murray Ducharme, Pharm.D., FCCP, FCPPresident and CEOLearn and Con�rm Inc.

John Peters, M.D.Director, Division of Clinical ReviewO�ce of Generic Drugs, FDA

Moderator: Molly RappVice President, Regulatory A�airsFresenius Kabi USA LLC

Lynne Ensor, Ph.D. Acting Division Director/Deputy DirectorDivision of MicrobiologyO�ce of Generic Drugs, FDA

Dominique Kendrick, R.Ph., RAC Senior Director, Regulatory A�airsSagent Pharmaceuticals, Inc.

5:00 p.m. – 7:00 p.m.Networking ReceptionGrand Ballroom Foyer

7:00 p.m. – 9:30 p.m.Dinner and EntertainmentGrand Ballroom

Wednesday, October 30, 20132013 GPhA/FDA Fall Technical Conference - Day 2

7:30 a.m. – 8:30 a.m. 2013 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 O�ce of Generic Drugs, FDA Johnny Young, M.A.L.A Regulatory Health Project Manager O�ce of Generic Drugs, FDA 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 A�airs, GPhA Iain Margand, R.Ph. Regulatory Support Management O�ce of Generic Drugs, FDA 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 O�ce of Generic Drugs, FDA

10:30 a.m. – 11:00 a.m. Networking Refreshment Break

11:00 a.m. – 11:45 a.m. Inactive Ingredients Update - FDA Robert Iser, M.S. Division Director Chemistry Division IV O�ce of Generic Drugs, FDA 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 A�airs, Impax Laboratories Nick Cappuccino, Jr. , Ph.D. Vice President Scienti�c A�airs, Dr. Reddy’s Laboratories, Inc. Kiran Krishnan Vice President – Regulatory A�airs, Apotex Corporation Suhas Patankar, Ph.D. Chemist, O�ce of Generic Drugs, FDA Susan Rosencrance, Ph.D. Deputy Director of Chemistry (Acting), O�ce of Generic Drugs, FDA

2:30 p.m. – 3:00 p.m. Networking Refreshment Break

3:00 p.m. – 3:45 p.m. O�ce of Generic Drugs Director’s Update Kathleen Uhl, M.D. O�ce Director (Acting), O�ce of Generic Drugs, FDA

3:45 p.m. – 4:30 p.m. Closing Remarks Moderator: David Gaugh, R.Ph. Senior Vice President, Sciences & Regulatory A�airs, GPhA Tony Amann, Ph.D. Executive Director, Regulatory and Medical A�airs, Roxane Laboratories Inc. Marcy Macdonald, RAC Vice President Regulatory A�airs, Impax Laboratories Richard Stec, Ph.D. Vice President, Global Regulatory A�airs, Perrigo Company 4:30 p.m. Conference Concludes