Changing Channels in the OTC Environment

May 13-14Hyatt Regency BethesdaOne Bethesda Metro Center7400 Wisconsin AvenueBethesda, MD 20814

chpa-info.org

2010 R e g u l at o R y & S ci e n t i fi c confeRence

PRogRam

changing channels in the OTC EnvironmentDay 1: Thursday, May 13

2010 R e g u l at o R y & S ci e n t i fi c co n fe R e n ce

Welcome to CHPA’s 2010 Regulatory and Scientific Conference (RSC).

Day one topics:

• Perspective on OTCs and dietary supplements from FDA senior leadership • Transforming uncertainty into competitive advantage

• The role of research in OTC and dietary supplement product development

• Regulatory and enforcement initiatives

may 13-14Hyatt Regency BethesdaOne Bethesda Metro Center7400 Wisconsin AvenueBethesda, MD 20814

meeting attire: business casual (no jacket/tie required)

infoRmation

SPonSoRed by

Gold LevelGlaxoSmithKline Consumer Healthcare

McNeil Consumer Healthcare

Silver LevelBayer HealthCare LLCConsumer Care

Merck Consumer Care

Novartis

Pfizer Consumer Healthcare

P&G

Bronze LevelPerrigo

1

Registration7:00 a.m. – 4:00 p.m. [Crystal Ballroom Foyer]

continental breakfast7:30 a.m. – 8:30 a.m. [Waterford/Lalique Rooms]

opening Session8:30 a.m. – 12:30 p.m. [Haverford/Baccarat Rooms] • Welcome Linda A. Suydam, D.P.A. President Consumer Healthcare Products Association

• Regulatory&ScientificAffairsCommitteeChairReport Sue E. James Vice President, Worldwide Regulatory Affairs, Compliance, Quality & EHS GlaxoSmithKline Consumer Healthcare [Chair, Regulatory & Scientific Affairs Committee]

• OverviewofRegulatory&ScientificConference John E. O’Mullane, Ph.D. Chief Scientific Officer Merck Consumer Care [Chair, Regulatory & Scientific Conference Planning Committee]

• UpdatefromFDASeniorLeadership Joshua M. Sharfstein, M.D. Principal Deputy Commissioner U.S. Food and Drug Administration

RefreshmentBreak10:00 a.m. – 10:30 a.m. [Waterford/Lalique Rooms]Sponsored by Concentrics Research LLC

Thursday, May 13

2010 R e g u l at o R y & S ci e n t i fi c co n fe R e n ce

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changing channels in the OTC EnvironmentDay 1: Thursday, May 13 (continued)

KeynoteAddress–“TheNewReality”10:30 a.m. - 12:30 p.m. [Haverford/Baccarat Rooms]

Karl Schoemer, M.B.A. Founder & PresidentVisionQuestBook giveaway sponsored in part by Pinney Associates, Inc.

Lunch12:30 p.m. – 1:30 p.m. [Waterford/Lalique Rooms]

Panel 11:30 p.m. – 3:30 p.m. [Haverford/Baccarat Rooms]

• TheScienceBehindtheProducts

Kerri J. McMahon, RAC [Moderator] Senior Associate, Regulatory Affairs

Bayer HealthCare LLC Consumer Care

PRESEntERS

Vidhu Bansal Dev, Pharm.D. Head of Medical Affairs, North AmericaGlaxoSmithKline Consumer Healthcare

Stephenie BarbaVice President, Global Regulatory AffairsMerck Consumer Care

Marc R. Gastonguay, Ph.D. President & CEOMetrum Research Group LLC

Dennis G. nelson, Ph.D.Vice President, R&D, OTC MedicinesMerck Consumer Care

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Mark Posno, Ph.D. Vice President, Business Development North-AmericaTNO

RefreshmentBreak3:30 p.m. – 4:00 p.m. [Waterford/Lalique Rooms]Sponsored by Pegus Research, Inc.

Panel 24:00 p.m. – 5:30 p.m. [Haverford/Baccarat Rooms]

• RegulatoryNewsfromCDRHandtheFTC

Leonard M. Baum, R.Ph. [Moderator]Vice President, Global Regulatory AffairsBayer HealthCare LLC Consumer Care

PRESEntERS

Angela Smith KruegerRegulatory Advisor Office of Device EvaluationCenter for Devices and Radiological Health U.S. Food and Drug Administration

Heather Hippsley, Esq.Assistant Director for the Division of Advertising PracticesU.S. Federal Trade Commission

EveningReception5:30 p.m. – 6:30 p.m. [Concourse Terrace] Door prizes sponsored by Accelovance, Inc.

Thursday, May 13

2010 R e g u l at o R y & S ci e n t i fi c co n fe R e n ce

changing channels in the OTC EnvironmentDay 2: Friday, May 14

Day two topics:

• Challenges and benefits from advances in social media

• FDA accomplishments and future plans

may 13-14Hyatt Regency BethesdaOne Bethesda Metro Center7400 Wisconsin AvenueBethesda, MD 20814

meeting attire: business casual (no jacket/tie required)

infoRmation

SPonSoRed by

Gold LevelGlaxoSmithKline Consumer Healthcare

McNeil Consumer Healthcare

Silver LevelBayer HealthCare LLCConsumer Care

Merck Consumer Care

Novartis

Pfizer Consumer Healthcare

P&G

Bronze LevelPerrigo

5

Friday, May 14

Registration 7:00 a.m. – 10:30 a.m. [Crystal Ballroom Foyer]

continental breakfast7:00 a.m. – 8:00 a.m. [Waterford/Lalique Rooms]

Panel 38:00 a.m. – 9:45 a.m. [Haverford/Baccarat Rooms]

• Welcome Barbara A. Kochanowski, Ph.D. Vice President, Regulatory Affairs Consumer Healthcare Products Association

• SocialMediaintheHealthcareProductSpace Dina R. Russello, BsChE, RAC [Moderator]

Director, Global Regulatory Affairs Johnson & Johnson Consumer & Personal Products Worldwide Division of Johnson & Johnson Consumer Companies, Inc.

PRESEntERS

W. Greg Collier, Ph.D. Associate Director of Product Safety, Safety Surveillance, and Oral Care Regulatory AffairsThe Procter & Gamble Company

Lt. Christopher M. Jones, Pharm.D., CSPITeam Leader, Safety and Risk Communication TeamOffice of CommunicationsCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

Friday, May 14

2010 R e g u l at o R y & S ci e n t i fi c co n fe R e n ce

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changing channels in the OTC EnvironmentDay 2: Friday, May 14 (continued)

Panel3continued PRESEntERS

Jim WalkerDirector, Emerging MediaCadient Group

Jeffrey n. Wasserstein, J.D.DirectorHyman, Phelps & McNamara, P.C.

PAnELIStS

F. Gail Bormel, R.Ph., Esq. Associate DirectorDivision of New Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

Murewa Oguntimein, MHS, CHESSocial Science AnalystDivision of Nonprescription Clinical EvaluationOffice of Drug Evaluation IVCenter for Drug Evaluation and Research U.S. Food and Drug Administration

Lt. tina WaltherConsumer Safety Officer, OTC TeamDivision of New Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

RefreshmentBreak9:45 a.m. – 10:15 a.m. [Waterford/Lalique Rooms]

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Panel 410:15 a.m. – 12:15 p.m. [Haverford/Baccarat Rooms]

• FDAUpdate

Brad Johnson, Ph.D. [Moderator]Section HeadRegulatory Affairs, Personal Health CareThe Procter & Gamble Company

PRESEntERS

Huascar BatistaTeam Leader, Import/Export Team Division of New Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

F. Gail Bormel, R.Ph., Esq. Associate DirectorDivision of New Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

Lesley-Anne Furlong, M.D.Medical OfficerDivision of Nonprescription Clinical EvaluationOffice of Drug Evaluation IVCenter for Drug Evaluation and Research U.S. Food and Drug Administration

Fathia Gibril, M.D.Deputy Director for SafetyDivision of Nonprescription Regulation DevelopmentOffice of Drug Evaluation IVCenter for Drug Evaluation and Research U.S. Food and Drug Administration

Friday, May 14

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2010 R e g u l at o R y & S ci e n t i fi c co n fe R e n ce

changing channels in the OTC EnvironmentDay 2: Friday, May 14 (continued)

Panel4continuedPRESEntERS

Dan D. Levy, Ph.D. Microbiologist, SupervisorNew Dietary Ingredient Review TeamCenter for Food Safety and Applied NutritionU.S. Food and Drug Administration Lonnie SmithProject Manager, Structured Product Labeling & eList TeamMedical Informatics Staff & FDA Data Standards CouncilU.S. Food and Drug Administration

PAnELIStS

M. Scott Furness, Ph.D. Director, Division of Nonprescription Regulation DevelopmentOffice of New DrugsOffice of Drug Evaluation IV Center for Drug Evaluation & Research U.S. Food and Drug Administration Andrea Leonard-Segal, M.D. Director, Division of Nonprescription Clinical EvaluationOffice of Drug Evaluation IVCenter for Drug Evaluation and Research U.S. Food and Drug Administration

• ClosingRemarksandAdjournmentJohn E. O’Mullane, Ph.D. Merck Consumer Care

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John E. O’Mullane, Ph.D.Chief Scientific OfficerMerck Consumer Care [Chair, RSC Planning Committee]

Francis P. Barbone, Ph.D.Director Global Regulatory AffairsNovartis Consumer Health, Inc.

Leah Christl, Ph.D. Associate Director for Regulatory AffairsOffice of Drug Evaluation IVOffice of New DrugsU.S. Food and Drug Administration[FDA liaison]

David W. Grob, M.S., RACDirector, Regulatory Affairs & SafetyChattem, Inc.

Angelina M. Hunt, RACDirector, Global Regulatory AffairsJohnson & Johnson Consumer & Personal Products WorldwideDivision of Johnson & Johnson Consumer Companies, Inc.

Brad Johnson, Ph.D.Section HeadRegulatory Affairs, Personal Health CareThe Procter & Gamble Company

RSC Planning Committee

changing channels in the OTC EnvironmentRSC Planning Committee (continued)

2010 R e g u l at o R y & S ci e n t i fi c co n fe R e n ce

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Kerri J. McMahon, RACSenior Associate, Regulatory AffairsBayer HealthCare LLC Consumer Care

Amy R. Replogle, M.S.Program Development Manager Merck & Co. Inc.

Dina R. Russello, BsChE, RACDirector, Global Regulatory Affairs Johnson & Johnson Consumer & Personal Products Worldwide Division of Johnson & Johnson Consumer Companies, Inc.

John A. Schalago, M.S., RAC Associate Director Regulatory AffairsPfizer Consumer Healthcare

Marcy L. Sussman Associate Director, U.S. Regulatory AffairsGlaxoSmithKline Consumer Healthcare

John C. Zhuang, Ph.D.Director, Regulatory Affairs McNeil Consumer Healthcare

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changing channels in the OTC EnvironmentDay 1: Thursday, May 13

2010 R e g u l at o R y & S ci e n t i fi c co n fe R e n ce

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2010 RSC Sponsors

Gold Level

Silver Level

Bronze Level

Refreshment Breaks

Prizes and Giveaways

Save the date: CHPA’s 2011 RSC • May 5-6 • Hyatt Regency Bethesda