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Succeedregulatory landscape

in the new



Now is the time



As the global economy and healthcare productindustry continue to reshape and challengeus in new ways, now is the time or regulatoryto thrive. Thrive as a dynamic pro ession thatis driving organizational strategy and sounddecision making throughout the product li ecycle.Thrive as individuals per orming vital work,making better healthcare products possible .

Connect

Your ability to develop and implement greatideas depends largely on the depth and breadtho your network. Being well-connected is not justabout meeting new aces; it’s about bringinginnovative ideas rom outside your organizationand putting them to use.

GrowWith over 2,000 regulatory pro essionals oryou to connect with, learn rom and share ideaswith, the 2009 RAPS Annual Con erence &Exhibition, 13–16 September in Philadelphia,provides you with the power to grow yournetwork and knowledge base with vitalconnections and in ormation that will bene tyou throughout the year.

It’s about knowledge, but it’s also aboutnetworks. Build yours at the 2009 RAPS AnnualCon erence & Exhibition and succeed in the new regulatory landscape.

Registration is now open.

to Thrive .

RAPS.org/ac2009

2009annual conference

&exhibition

R A P S

13–16 September 2009

PhiladelphiaPennsylvania Convention Center



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:: Keynote AddressJim Collins

Author o best-selling business book Good to Great andco-author o Built to Last , Jim Collins is a renowned experton enduring great companies––how they grow, how theyattain superior per ormance, and how good companies canbecome great companies. He is author or co-author o ourbooks, and his work has been eatured in Fortune , The Wall

Street Journal , Business Week , Harvard Business Review and Fast Company .His most recent book, Good to Great: Why Some Companies Make the Leap…And Others Don’t , has sold three million hardcover copies and has beentranslated into 35 languages.

:: Thank You to Our Sponsors

Table of Contents

Did you know all of these greatnetworking activities are includedwith your conference registration fee?

• Share new ideas with colleagues duringthe continental break asts , lunches, re reshment breaks and eveningreceptions

• Make potential career connections at theCareer Center

• Access 100+ new innovative products inthe Exhibit Hall

• Participate in the new interactive SituationRooms eaturing hot issue regulatorytopics acilitated by RAPS Fellows

This is your opportunity to make valuablepro essional connections!

Connect!RAPS.org/ac2009 has everything you need to make the most o your Annual Con erence

experience. Sign up or the con erence Twitter eed, review the list o related products, let

your colleagues know you are attending through the Annual Con erence Facebook page,

fnd out about not-to-miss con erence highlights and much more!

Schedule at a Glance ..............................................................................3

Conference Highlights ............................................................................3

Preconference Workshops ......................................................................5

Session Descriptions ............................................................................... 6

Biologics/Biotechnology ................................................................6

Business ...................................................................................8

Clinical ...........................................................................................9

Combination Products .................................................................11

Compliance and Audits................................................................13

Medical Devices and I VDs ...........................................................14

Pharmaceuticals ..........................................................................17

Conference Registration ........................................................................20

Speakers ...............................................................................................20

Session Leaders ....................................................................................20

About Philadelphia ................................................................................21

The RAPS Business and LeadershipSeries equips you with the tools topregulatory managers require. VisitRAPS.org/business to learn more.

* Sponsors con rmed at press time. Visit RAPS.org/ac2009 or the latest list o sponsors.



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:: Schedule at a GlanceSATURDAY, 12 SEPTEMBER4:00–7:00 pm Registration, Speaker Ready Room and Bookstore Open

SUNDAY, 13 SEPTEMBER7:00–8:30 am Continental Break ast7:00 am–6:00 pm Regist rat ion , Speaker Ready Room, Bookstore and RAPS In ormat ion Sta tion Open8:30 am–5:00 pm Precon erence Workshops10:30–11:00 am Re reshment Break12:30–6:00 pm Career Center Open12:30–1:30 pm Lunch3:00–3:30 pm Re reshment Break

MONDAY, 14 SEPTEMBER7:00–8:30 am Continental Break ast7:00 am–5:00 pm Registrat ion, Speaker Ready Room, Bookstore, Career Center and RAPS In ormation Station Open8:30–10:00 am Keynote Address & Fellows Induction10:00 am–6:00 pm Exhibit Hall Open10:00–11:00 am Re reshment Break11:00 am–12:00 pm Concurrent Educational Sessions12:00–1:30 pm Lunch12:00–1:30 pm Prepare or the RAC Exam12:30–1:15 pm Situation Rooms1:30–3:00 pm Concurrent Educational Sessions3:00–3:30 pm Re reshment Break3:30–5:00 pm Concurrent Educational Sessions5:00–6:00 pm Exhibitors’ Reception6:30 pm Dine-Arounds

TUESDAY, 15 SEPTEMBER6:15–7:00 am RAPS Foundation 5K Fun-Run7:30–8:30 am Continental Break ast7:30 am–5:00 pm Registrat ion, Speaker Ready Room, Bookstore, Career Center and RAPS In ormation Station Open8:30–10:00 am Concurrent Educational Sessions10:00 am–3:30 pm Exhibit Hall Open10:00–10:30 am Re reshment Break

10:30 am–12:00 pm Concurrent Educational Sessions12:00–1:30 pm Lunch12:30 –1:15 pm Situation Rooms1:30–3:00 pm Concurrent Educational Sessions3:00–3:30 pm Re reshment Break3:30–5:00 pm Concurrent Educational Sessions6:00–8:00 pm RAPS Annual Celebration Reception

WEDNESDAY, 16 SEPTEMBER7:30–8:30 am Continental Break ast7:30 am–12:00 pm Regist rat ion , Speaker Ready Room, Bookstore and RAPS In ormat ion Sta tion Open8:30–10:00 am Concurrent Educational Sessions10:00–10:30 am Re reshment Break10:30 am–12:00 pm Concurrent Educational Sessions

12:00–2:00 pm Closing Luncheon, Keynote Address and Awards Presentation

Conference HighlightsAnnual Celebration ReceptionGet the evening started right! Join your colleagues

or a night o un and celebration at RAPS’ largestsocial gathering o regulatory pro essionals.

Awards Presentation and Closing LuncheonRecognize the hard work, dedication, leadershipand accomplishments o your colleaguesas they are honored or their outstandingcontributions to the regulatory pro ession.

Dine-AroundsAnd you thought it was all cheesesteaksand pretzels! Many o the best and mostinnovative restaurants in the US can be ound inPhiladelphia, and within steps o the PennsylvaniaConvention Center. Join your colleagues orspirited conversation over great ood and drink.

Exhibitors’ ReceptionJoin your ellow con erence attendees andexhibitors or riendly conversation, ood anddrink at this special networking reception––the rst big social event o the con erence!

RAPS FellowsEngage RAPS Fellows in thought-provokingconversations in the new Situation Rooms andthroughout the con erence. Watch the 2009Class be inducted as new Fellows are recognized

or their contributions to the pro ession.

NEW! Situation Rooms

Participate in provocative situation roomsacilitated by RAPS Fellows that delveinteractively into today’s hottest topics.



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:: Preconference WorkshopsRegister early or one o RAPS’ popular precon erence workshops!Increase your competitive advantage, improve your marketability andadvance your career. I you are new to the regulatory pro ess ion, changingproduct lines/industry or preparing to take the RAC exam, these programswill be o great bene t to you. Taught by highly-regarded regulatorypro essionals, these workshops cover the latest in ormation in a oruminvolving open dialogue between participants and instructors. Join us or astimulating learning experience.

THE REGULATORY ESSENTIALS SERIES

These one-day programs o er concise, comprehensive, invaluableoverviews o the essentials o regulatory knowledge or thepharmaceutical, biologics and medical device industries in various regionsaround the globe.

Regulatory Essentials: Canada• Canada’s Regulatory Environment• The Impact o Regulatory Changes• Premarket Requirements and Submissions: Devices, Drugs, Biologics,

Combination Products and Natural Health Products• Clinical Trials (All Product Lines)• Postmarket Requirements and Reporting (All Product Lines)• Environmental and Provincial Regulations• Advertising, Promotion and Labeling

Regulatory Essentials: EU• Overview o EU Medicinal Products and Medical Devices Legislation• Medicinal Products: Clinical Trials• Medicinal Products: Marketing Applications• Medicinal Products: Postmarketing Requirements• Medical Devices: Classi cation• Medical Devices: Con ormity Assessment• Medical Devices: Technical Documentation• Medical Devices: Postmarketing Activities•

Combination ProductsRegulatory Essentials: Japan• Overview o Japan’s Healthcare Environment• Japan’s Government Agencies• The Basics and Overview o Regulatory Submissions• Regulatory Submission Obser vations From the Reviewer’s Perspective

and Commonly Cited De ciencies• Undertaking Topicals: Quality, Third Party Review and Clinical Studies• Perspectives on Pharmaceutical and Biologics Requirements

Register early or one o these popular precon erenceworkshops. These programs sell out!

RAPS.org/ac2009

Regulatory Essentials: US• Brie History o Medical Product Regulation• FDA Organizational Review• Overview o Drugs and Biologics• Overview o Medical Devices• Advertising, Labeling and Promotion or Drugs, Biologics and Devices• Postmarketing Requirements or Drugs, Biologics and Devices• Compliance and En orcement

EFFECTIVE MEDICAL WRITING

Medical writing plays a crucial role in speeding product submission andsupporting compliance and the bulk o it is regulatory. Regulatory writing

is an integral part o the product development and approval process.It includes protocols, clinical study reports , investigator’s brochures,investigational and product applications, FDA brie ng documents,integrated summaries o e cacy and sa ety, manuscripts, abstracts,posters, meeting coverage and product labeling. In this precon erenceworkshop, participants learn e ective medical writing, Dos and Don’ts,and the di erences between poor and high-quality writing. Speci c issuesinclude:• Good Writing Practice• Writing High Quality Medicinal Product and Medical D evice Study

Reports• E ective Management and Quality Control o Medical Writing Tasks• Medical Writer’s Role in Marketing Application Submissions

NEW! ADVERTISING, PROMOTION AND LABELING

The regulatory environment or the advertising and promotion o healthcareproducts continues to evolve with F DA, OIG and industry initiatives.

In this unique program designed or mid-level pro essionals, RAPS willbring together leading experts rom industry, government and the legalpro ession to share vital in ormation on the latest regulations, guidelines,en orcement actions and trends that may impact the advertising,promotion and labeling o medical devices and phar maceuticals.

Read why last year’s attendees thinkthat the RAPS Annual Con erence is amust-attend event:

“Great conference; I really enjoyed the preconference workshop (really useful!)…Bravo!I will surely come back next year!”

“Excellent programs and presenters.Very knowledgeable.”

“Wonderful avenue to network and gainknowledge of the profession.”

“One of the best conventions I have attended interms of presentations.”

“The RAPS event is very helpful in providing high- level information and networking with colleaguesfrom the same areas of interest.”

“The event was very well d one.”



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:: Session Descriptions

:: BIOLOGICS/BIOTECHNOLOGY

MONDAY, 14 SEPTEMBER

Gene Therapy: History and Current Status11:00 am–12:00 pm | Professional Levels: I, IIWhile curing diseases caused by genetic de ects by introducing geneticmaterial into individual cells may o er a signi cant medical bene t, genetherapy also has the potential to cause serious harm or even death. Asa result, nearly 20 years a ter the rst demonstration in humans, a gene-therapy-based product still lacks approval. Senior regulatory manager Cindy Fisher, PhD, will lead the discussion on recent developments romthe Center or Biologics Evaluation and Research’s O ce o Cellular,Tissue and Gene Therapy, to provide you with an understanding o what ittakes to conduct clinical research and to develop a gene therapy productin today’s highly controlled regulatory environment.

Regulatory Models or Biosimilars

1:30–3:00 pm | Professional Levels: II, III, IV In this session, legal expert Michael A. Swit, Esq ., will brie participantson the progress o pending bills in Congress that may provide a statutorypath or biosimilars as the 1984 Hatch-Waxman Act did or drugs. TheEuropean regulatory system’s approach to generic biologics w ill also bereviewed; and comparability and techniques or proving bioequivalencewith products that appear similar, but present signi cant variations inimmunogenicity will be discussed. You will be able to give your companya better understanding o how the new model or generic biologics maydi er rom the small molecule model, and how t hat will create a di erentmarket or these products.

Visit RAPS.org/ac2009 or the latest andmost complete con erence in ormation.

Moving Stem Cell Products Into the Clinic3:30–5:00 pm | Professional Levels: II, III

With much o the stem cell ocus on research and development, not on theregulatory questions, many products are in the IND stage o development withno proven regulatory pathway or approval. Led by Debora Lavoie, JD, RAC,this session will explore how regulatory agencies and industry are developingregulations or cell and stem cell product development, preclinical andclinical trial design, to enable uture product approvals or needed medicalinterventions.

TUESDAY, 15 SEPTEMBER

CBER Executive Sta Briefng8:30–10:00 am | Professional Levels: I, II, III, IV

Global regulatory a airs expert Douglas Hunt will lead FDA’s Center orBiologic Evaluation and Research (CBER) sta in a discussion about andan update on recent activities and trends, as well as upcoming initiativesand current developments. You will take home critical in ormationimpacting your organization.

Submitting a BLA10:30 am–12:00 pm | Professional Levels: II, III

Many start-up companies have little or no experience in submitting BiologicLicense Applications (BLAs). FDA regulatory expert and consultantJoyce Frey-Vasconcells and other experienced pro essionals will discuss the FDAprocess and o er insights into regulatory strategies and timelines to help youmeet all requirements or success ul, approvable and timely BLA submissions.

Counter-Bioterrorism Agents and the Animal Rule1:30–3:00 pm | Professional Levels: II, III

In this session, William Egan, PhD, and speakers rom both government

and industry will address legal and regulatory issues regarding biologics/vaccines and the basics o FDA’s “Animal Rule”—what it can and cannotdo and how it is being implemented in the development o counter-bioterrorism biological agents.

Biopharmaceutical Preclinical Safety Evaluation: The Case-by-Case Approach3:30–5:00 pm | Professional Levels: II, III

To sa ely introduce novel therapies into clinical trials, preclinical sa etyevaluation programs or biopharmaceuticals are customized based uponspecifc product attributes (i.e., the case-by-case approach) and enhancedutilizing experience with similar products. In this session, toxicology expertJoy Cavagnaro, PhD, RAC, will lead current and ormer FDA regulatoryscientists in a discussion o key considerations or the success ulimplementation o the “case-by-case” approach and how to better predictwhether programs will be acceptable to regulators. Presentations will addressrecombinant proteins, monoclonal antibodies, and cell and gene therapies.

WEDNESDAY, 16 SEPTEMBER

Defning Homologous Use8:30–10:00 am | Professional Levels: II, III

Many companies think they have a tissue product that is or homologoususe and are surprised when they receive noti cation rom FDA indicatingotherwise. You will learn how to interpret and apply the criteria or HCT/Ptissue regulation, as well as other in or mation needed or FDA submission,in this session led by regulatory and tissue expert Joyce Frey-Vasconcells.



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Grow your network



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:: CLINICAL


New Pregnancy and Lactation Labeling Rule Revisions11:00 am–12:00 pm | Professional Levels: I, II

In 2008, FDA proposed major revisions to prescription dr ug labeling,requiring that detailed in ormation be provided about the use o drugs/biologics by women who are pregnant, nursing or o childbearing age.Led by regulatory expert Lisa Jenkins, PhD, this session will give you anoverview o the proposed rule and provide current in ormation on design o lactation studies.

CASE STUDY: Adaptive Clinical Trial Designs That Get Results1:30–3:00 pm | Professional Levels: III, IV

The proper use o adaptive clinical trial design can lead to moree cient data collection, a higher probability o success and quickerdrug development. Led by regulatory expert Lisa Jenkins, PhD, thissession will review changes to regulations and guidances impactingthe use o adaptive clinical trials and present you with perspectives

rom regulatory agencies (Health Canada and FDA) on the variousdesign methodologies. You also will learn about recent developmentsin the Canadian Progressive Licensing Project that bear on the use o adaptive trial designs during early and late stage development.

Clinical Trial Requirements: Similarities and Di erences (US, EU andJapan)1:30–3:00 pm | Professional Levels: II, III

Globalization o marketing applications a ects the preclinical, clinicaland postmarketing phases o the healthcare product li ecycle. In thissession led by compliance expert Anita Fenty, MS, RAC , you will reviewthe similarities and di erences in clinical trial and adverse event reportingrequirements among the US, EU Member States and Japan. How to bestapply this in ormation throughout the preclinical through marketing phaseswill also be covered.

FDA Requirements or Using ClinicalTrials.gov 3:30–5:00 pm | Professional Levels: I, II, III, IV

Clinical studies are a critical component o getting your product approvedand onto the market. Requirements or clinical trial registration and studypublication have changed signi cantly, and ailure to register your trialcould mean results will never get published. Your company could get nedup to $10,000 per day i you don’t disclose the study results within a year,regardless o the status o your FDA submission. Led by clinical studiesspecialist Karen Bannick McQuoid, MA , this session will update you onnew and evolving FDA requirements and show you how to get trial resultspublished and available to the scienti c community.


Designing Clinical Trials With the Target Product Profle in Mind10:30 am–12:00 pm | Professional Levels: II, III

Placing an emphasis on the nal product label early in development canproduce signi cant bene ts as you approach commercialization. In thissession led by regulatory expert John Wood , you will learn how to establisha labeling strategy and leverage t ools like FDA’s Target Product Pro le tostreamline development and ensure important commercial messages are

built into the overall process.

Top 10 Mistakes Sponsors Make in Clinical Trials1:30–3:00 pm | Professional Level: II

Led by clinical study consultant Jillian Reed , this session will make youaware o the top 10 pit alls medical device sponsors commonly encounterduring clinical trials, such as investigational site selection, monitoringnightmares and missed enrollment deadlines. This in ormation w ill helpyou assess both current and uture clinical trials with an increasedknowledge o how to complete your study success ully and get yourproduct to market with minimal mistakes along the way.

Ethical Standards in Clinical Research3:30–5:00 pm | Professional Levels: I, IIMany experts believe individual institutions and associations shouldadopt stricter standards o conduct in clinical research than thoserefected in current ederal regulations, which do not hold investigatorsor institutions responsible or supervising and training clinical trial sta .Led by development program expert William Sietsema, PhD, this sessionwill show you how to recognize and address raud and misconduct— romimproper patient protection and alsi cation o data to sponsor paymentsto investigators or nonclinical study-related expenses and disclosureobligations under 21 CFR Part 54.

Don’t miss the new Situation Rooms . These interactive sessions provide dynamic learningon current hot topics acing the regulatory pro ession

in a town hall style ormat!

RAPS.org/ac2009



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Using Postmarket Surveillance Data or Medical Devices8:30–10:00 am | Professional Levels: II, III

For medical device companies, it is challenging to assess the sa ety o devices with only clinical trial data. This session will make you awareo special sa ety review considerations or clinical trials in light o riskmanagement requirements established by ISO 14971, and strategies orintegrating postmarket surveillance elements.

Preparing or FDA Audits o Clinical Studies10:30 am–12:00 pm | Professional Levels: I, II

Many procedures need to be developed and implemented to prepare asite or an FDA bioresearch monitoring (BIMO) inspection, which ocuseson speci c areas such as risk management processes. In this sessionled by quality assurance and control expert Gloria Miller, RAC, you willget an overview o FDA’s BIMO program, including what to expect rom aninspection, how to develop procedures to ensure your site is ready andwhat needs to be done a ter the act.

RAC ANDCONTINUING EDUCATION CREDITSFull con erence attendees will receive 12 RAC recerti cation credits

or con erence attendance and 6 credits or precon erence workshopattendance. In addition, many Annual Con erence sessions are eligible

or pharmacy continuing education credit. Visit RAPS.org/ac2009 ormore in ormation. Extension Services in Pharmacy at the Universityo Wisconsin–Madison School o Pharmacy is accredited by theAccreditation Council or Pharmacy Education as a provider o continuingpharmacy education. Statement o credit or continuing pharmaceuticaleducation participation will be mailed within six weeks o receipt o completed evaluations.

:: COMBINATION PRODUCTS


Tissue Engineered Combination Products—Coordination Is Key11:00 am–12:00 pm | Professional Level: II

Tissue engineered products o ten consist o a biologic and a device,each o which can potentially be produced by a di erent company. Led bytissue expert, Joyce Frey-Vasconcells, this session will present a detailedanalysis o the complexity and critical components o developing a tissueengineered product and the regulatory considerations involved. Theinteraction and coordination between di erent organizations within andoutside your company that may come into play will be discussed.

Cross Labeling–Fact or Fiction?1:30–3:00 pm | Professional Levels: II, III

In 2005, the O fce o Combination Products (OCP) held a con erence on thecross labeling “problem.” In 2008, OCP issued guidance on New ContrastImaging Indications. Led by regulatory specialist Suzanne O’Shea, JD, thissession will examine whether cross labeling really poses a signifcant problemand what OCP’s guidance suggests about the uture o cross labeling. You willlearn how separately marketed products might be considered combination

products through labeling, when cross labeling is and isn’t required, somecreative possibilities and whether it can ever work to your advantage.

Postapproval Changes or Combination Products3:30–5:00 pm | Professional Levels: I, II, III, IV

New technologies and advances in medical practice have served ascatalysts or the introduction o combination products that o er sa er,more e ective and convenient treatments or patients. In this sessionled by regulatory specialist Raymond Seda, MBA, RAC, you will gain anunderstanding o FDA’s O ce Combination Product (OCP) perspective and

uture initiatives and its role on guidance o and interaction with the leadcenters (CDRH, CDER, CBER). Applicable postapproval requirements andpractical examples o postapproval changes or combination productsregulated as devices, drugs and biologics w ill be covered.

CASE STUDY: Navigating the Scientifc and Regulatory Dividing LineBetween Drugs and Devices3:30–5:00 pm | Professional Levels: II, III

Led by combination product consultant and expert Miriam Provost, PhD,this session will review the regulatory defnitions or drugs and devicesand provide insight into how these defnitions may overlap. The legal,regulatory and scientifc bases or jurisdictional determinations regardingchemical mode o action and how to resolve issues will be discussedthrough examples and case studies.



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CASE STUDY: Combination Product Regulation in Asia8:30–10:00 am | Professional Levels: II, III

Global regulatory expert Nigel Hernandez, PhD, RAC, will leadthis session addressing current and uture regulatory initiatives,legislation and requirements or combination products in China andJapan, including the ramework and bodies (e. g., China’s SFDA re-registration requirements and type testing requirements and Japan’sPMDA and MHLW), the consultation process and relevant dra tregulations. Case studies and important elements or combinationproducts will be discussed, as will ASEAN and the commonsubmission dossier template.

Shedding Light on New Rules or Adverse Event Reporting10:30 am–12:00 pm | Professional Levels: I, II, III, IV

In recent years, the combination products industry has grappled withhow to address conficting rules or reporting adverse events. FDA haspublished a concept paper on a proposed rule. Led by regulatory lawexpert Bradley Thompson, MBA, JD, RAC, this session will teach you howto apply current requirements t o your company’s products and operationsat both a strategic and tactical level. Industry reactions to the proposedrule, implications or drug and medical device companies that marketcombination products and case studies relevant to implementation will bediscussed.

OCP Executive Sta Briefng1:30–3:00 pm | Professional Levels: I, II, III, IV

Most experts predict that combination products will continue to be asigni cant growth area or the healthcare industry. Industry expert and

ormer OCP Director Mark Kramer, RAC, will moderate this sessioneaturing leadership rom FDA’s O ce o Combination Products (OCP)

discussing priorities and current policy initiatives, key regulations andguidance documents. You will bene t rom the insight and perspectives o

the Combination Products Coalition, a leading advocacy group or policy onregulatory issues a ecting combination products.

RAPS Foundation 5K Fun-Run

Climb the amous “Rocky Steps” at the PhiladelphiaMuseum o Art, and see a bit o Philadelphia in this brie jog

around Philadelphia’s historic neighborhoods.(Separate on-site registration required).


CASE STUDY: FDA’s New Approach to Good Manu acturing PracticeRequirements8:30–10:00 am | Professional Levels: I, II, III

Currently, there are no regulations describing or prescribing GoodManu acturing Practices or combination products, and there isrecognition within FDA, industry and the legal community that urtherregulatory and inspectional clarity and guidance are needed. Led byregulatory law expert James Cohen, Esq. , this session will provide youwith an overview o FDA’s proposed rule on CGMPs or combinationproducts, the legal basis and rationale, the implications or deviceand drug companies, case studies on how to meet the requirements,alternatives to the proposed rule and views on whether FDA’sapproach is the appropriate one or the agency and industry.

Traversing the Canadian Regulatory Landscape8:30–10:00 am | Professional Levels: I, II, III

You will learn the route your combination product must take in theCanadian approval process and hear in ormation on Canada’s currentregulatory environment or combination products in contrast with other

jurisdictions in this session led by Canadian regulatory expertMary Speagle, RAC . Discussions will include the role o the TherapeuticProducts Classi cation Committee and application techniques or variouspolicy and illustrative case studies will be presented along with upcominginitiatives under the Blueprint for Renewal .

Impact o EU Rules Governing Devices on Combination Products10:30 am–12:00 pm | Professional Levels: II, III, IV

EU regulatory expert Elisabethann Wright, will lead this sessionaddressing current and uture initiatives, legislation and regulatoryrequirements or combination products. European Commission proposalsto modi y current EU medical devices legislation and stakeholders’opinions on those proposed changes will be examined. Implications o therevision to the Medical Devices Directive that will enter into orce in 2010and other expected regulatory changes in coming years, or both medicaldevices currently in development and pipeline products, will be examined.



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:: COMPLIANCE AND AUDITS


Good Clinical Practice Compliance in Clinical Trials11:00 am–12:00 pm | Professional Levels: I, II

Individuals rom pharmaceutical companies, contract research organizations(CROs) and academic institutions involved with the supervision or oversighto clinical trials will learn the principles and requirements or Good ClinicalPractices (GCPs) in this session led by compliance expert Gloria Miller, RAC.FDA and ICH requirements or sponsors, monitors and investigators will becovered and techniques or evaluating compliance levels at clinical sites andhow to implement corrective/preventative actions to ensure optimum GCPcompliance will be introduced.

Drug/Biologic Preapproval Inspection (PAI)—A Survival Guide1:30–3:00 pm | Professional Level: II

All pharmaceutical and medical device manu acturers are encouraged to beprepared or FDA inspections regardless o whether a pre-announcementhas been received. In this session led by senior regulatory consultantHarindranath Nagaradona, PhD, you will examine the steps that a companywould implement to prepare or and ensure a success ul preapproval

inspection (PAI), including developing corporate SOPs to consistentlymanage inspections at all applicable sites, properly training personnel at alllevels, and interacting with FDA investigators in a positive manner.


How to Respond to a Warning Letter8:30–10:00 am | Professional Levels: III, IV

This session, led by regulatory consultant Susan Jacobs , will reviewelements o regulatory inspection responses and outline key areas o evaluation you should consider be ore replying t o an inspection or WarningLetter, including corrective and preventive action target completions. Howto respond to FDA Form 483, what in ormation and the level o det ail to

include, appropriate time rames, and who should interact with the FDAdistrict o ce will be discussed.

Addressing Good Laboratory Practice (GLP) Testing Concerns1:30–3:00 pm | Professional Levels: II, III

Drug, device and/or chemical submissions all require GLP processes.I these initial data are not veri ed, robust and well documented, allsubsequent in ormation may be inadmissible. Led by GLP specialist AmyWright, PhD, RAC, this session will introduce you to areas o concern withGLP testing in the early stages o new product development, includingpotential GLP preclinical testing issues involving an “in house” lab orcontract research organization, and how the regulatory pro essional can bemore aware o QA needs.

Key Points or GMP-Production Compliance3:30–5:00 pm | Professional Level: II

Understanding the key requirements o Good Manu acturing Practice(GMP)-production compliance is essential or regulated industry. Led bycompliance expert Robert Schi , PhD, RAC, this session will cover theGMP regulations, documentation requirements, corrective and preventiveaction (CAPA) plans, sel -examination and internal auditing. Compliance

rom the receiving area to the warehouse, staging, manu acturing,packaging, shipping and quality control, and areas o FDA inspection ocuswill be discussed.


Validation Compliance: What’s Required?8:30–10:00 am | Professional Level: II

Having a rm understanding o what areas require validation andquali cation to meet FDA expectations is critical to the regulatoryprocess. This session will provide an overview o method validation orquality control, puri ed water and trans er validation. Key expectationso regulators on validation and the di erences between quali cation andvalidation will be summarized and demonstrated.

Success ully Completing Failure Investigations and OOS10:30 am–12:00 pm | Professional Level: II

Led by compliance training specialist Hal Dayton Hopkins , this sessionwill give you an outline o the process or robust ailure investigationsand out-o -speci cation (OOS) investigations or r egulated industry.The key elements in completing and documenting investigations toachieve regulatory expectations will be discussed, and best practices

or determining root cause and ensuring closed loop systems orinvestigations will be reviewed.

Visit the Career Center

Confdentially browse open regulatory positions,pick up career related literature rom leading employers

and use the drop box to submit your resume.

RAPS.org/ac2009



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:: MEDICAL DEVICES AND IVDS


The Future o GHTF?11:00 am–12:00 pm | Professional Levels: I, II, III, IV

The Global Harmonization Task Force (GHTF) was established in 1992in an e ort to achieve greater uni ormity among national medical deviceregulatory systems. In this session led by international regulatory specialistRainer Voelksen, you will hear rom GHTF representatives on the impactand bene ts o current initiatives or the medical device industry. Therecently developed guidance on supplier quality and a new guidance onCAPA, as well as in ormation on new countries using or considering GHTF-type systems when introducing a new regulatory ramework, will be covered.

Registration is easy!

Visit RAPS.org/ac2009 or more in ormationon how to register online, by ax or phone.

Common Pit alls and Best Practices in CLSI Study Design11:00 am–12:00 pm | Professional Levels: I, II, III, IV

Understanding the analytical and clinical study requirements to support asuccess ul IVD submission is key to getting your new product approved.In this session led by regulatory expert Juliet Carrara, RAC, you will learnabout the applicable regulations, guidance and standards and increaseyour ability to provide appropriate guidance to enhance your credibilitywithin your organization and with reviewers. Discussions will address howto identi y applicable standards; when to do analytical (bench) testingversus clinical studies; and examples o success ul and ailed proposals

or alternatives to Clinical and Laboratory Standards Institute study design.

CDRH Executive Sta Briefng1:30–3:00 pm | Professional Levels: I, II, III, IV

In this session led by policy expert Mark Gordon, MS, RAC, you willhear a detailed review o the past year at FDA’s Center or Devicesand Radiological Health (CDRH) as well as an overview o initiatives,milestones and current trends or the next year. You will hear directly romsenior-level CDRH and industry pro essionals and you’ll take home criticalin ormation impacting your organization.

A Deeper Understanding o Companion Diagnostics3:30–5:00 pm | Professional Levels: I, II, III, IV

You will discuss personalized medicine, types o companion diagnostics,labeling considerations and case studies on development and regulatorystrategy in this session led by senior regulatory expert James Kelly, PhD .Agency and industry perspectives will be included in the discussion.

PMDA Update: Future Initiatives and Challenges3:30–5:00 pm | Professional Levels: II, III

In this session, led by Japanese regulatory expert Kyoichi Tadano, PhD, heardirectly rom senior o fcials o Japan’s Pharmaceuticals and Medical DevicesAgency about PMDA’s Fiscal 2009–2013 second midterm action and policyplan. Speakers will outline the second midterm plan and discuss utureagency directions, as well as PMDA’s current initiatives and challenges orquicker medical device review and more e ective li ecycle management.

A 2010 Approach to the Medical Devices Directive (MDD )3:30–5:00 pm | Professional Levels: I, II, III, IV

Led by medical device expert Gary Barrett , this session will brie youon various MDDupdates that will enter into orce in March 2010 andprovide you with an update on IVD regulations. MDDchanges, including:EU expectations and direct e ects on manu acturers; changes in labelingand instructions or use, single use, risk analysis, postmarket surveillance,clinical and technical les/dossiers and the essential requirements; andhow these changes a ect certi cation will be discussed.


FDA O fce o IVD Evaluation and Sa ety Special Topics8:30–10:00 am | Professional Levels: I, II, III, IV

The transition o products rom an unregulated environment to one withregulations can provide many unique challenges including analyte speci creagents (ASRs), laboratory developed tests (LDTs) and IVD MultivariateIndex Assays (IVDMIAs); closed and open laboratory instrumentation;and de novo downclassi cation. This session led by Rose Romeo, PhD,will provide examples o such transitions involving products that can nowbe viewed as in vitro diagnostic medial devices. Case histories will bepresented or situational analysis o topics ranging rom initial planning tosubmission planning and overall compliance activities.

Emerging Markets: Regulatory Challenges and Considerations8:30–10:00 am | Professional Levels: II, III

With the slow moving market in the West, more companies are looking toemerging markets to expand sales. Regulations in emerging markets areless mature and present many obstacles to Western businesseshoping to gain entr y. This session, led by medical device consultantChang-Hong Whitney, MBA, will ocus on the regulations and regulatorychallenges in the emerging markets o China, Taiwan and South America.

The Pennsylvania Convention Center is c entrally locatedin downtown Philadelphia in close proximityto the city’s abulous restaurants and sights.



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Impact the profession



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Japan in Focus: Regulations or Medical Devices10:30 am–12:00 pm | Professional Levels: II, III

This session, led by Japanese regulatory expert Yuka Suzuki, PhD,will provide you with in ormation on current regulatory processes andbasic requirements or medical device registration in Japan. In addition,regulatory and industry representatives will discuss the current status andchallenges acing the cooperative Japanese-US e ort, Harmonization byDoing (HBD), and its impact on international regulatory harmonization ormedical devices.

Unique Device Identifcation—Requirements and Considerations10:30 am–12:00 pm | Professional Levels: I, II, III, IV

The establishment and implementation o a Unique Device Identi cationSystem (UDI) is required by the Food and Drug Administration Amendments

Act o 2007. Led by data standards expert Dennis Black, this sessionwill give you an understanding o the UDI Law and FDA’s perspective onregulation, US market needs and mandates, ways UDI aligns with currentmanu acturing processes and business practices, global UDI needs andkey implementation considerations. E orts toward developing a global UDI

or medical devices will be addressed.

CASE STUDY: Identi ying Premarket Medical Device Issues1:30–3:00 pm | Professional Levels: II, III

In this session led by quality and regulatory a airs expert Joel Kent,RAC, you will be given a background on the subjects o FDA pre-IDE(investigational device exemption) processes or medical devicesand Canadian medical device submissions. You will participate insmall groups to review various case studies presented and proposeworkable solutions.

Improving Postmarket Device Surveillance with Healthcare Pro essionals1:30–3:00 pm | Professional Levels: II, III

This session will include a discussion o the review o surveillance areassuch as signi cant adverse events and medical device reporting and theirlinks to management review, complaint boards and recalls, as well as theneed to communicate this expertise to healthcare pro essionals.

A Closer Look at Standards or Medical Devices3:30–5:00 pm | Professional Levels: II, III

This session will address the increasing role that standards (design,testing, labeling) are playing as de facto requirements or global premarketsubmissions, and why regulatory pro essionals need to understand moreabout this increasingly critical area. The discussion will include a lookat how emerging developments and trends are shaping medical deviceregulation.

CASE STUDY: Noncompliance Risks in Labeling, Advertising andPromotion3:30–5:00 pm | Professional Levels: I, II

To educate the medical device developers and users about thestandards against which the devices will be evaluated and potentialrisks o noncompliance with labeling, advertising and promotionalmaterial review processes, regulatory reviewers should be well-versedon logistics and well-in ormed about the timing, audience and deliverymode o the devices. Led by senior regulatory specialist VirginiaGarcia, RAC, this session will provide you with a valuable overviewand demonstrate speci c examples o how to communicate with keystakeholders to improve the e ciency o the review process.


CLIA: Ensuring Quality Laboratory Testing8:30–10:00 am | Professional Levels: I, II, III, IV

This session, led by Brooke Bumpers will review the Clinical Laboratory Improvement Amendments (CLIA) o 1988, CLIAregulations orlaboratories, FDA CLIAComplexity Categorization Process and CLIAWaiverApplications or in vitro diagnostics. Reimbursement considerations andprocesses will be discussed. You will take away strategies that can be

implemented within your organization to improve business.

Practical Tips or Implementing Quality Systems10:30 am–12:00 pm | Professional Levels: I, II

The time and cost to implement and maintain a quality system are a biginvestment and can be burdensome or small companies. In this session ledby medical laboratory technology specialist Nancy Ruth, RAC, you will learnhow to ensure the quality system is designed to meet requirements or yourcompany’s target markets, including documentation and implementationstrategies, selection o certifcation bodies, auditor inter ace, avoiding gapsin the audit process and getting the most value or your investment. ISO13485:2003 or Canada, the EU and the US FDA Quality System Regulationwill be covered.

Have Your RAC?

Earn up to 12 recertifcation credits byattending this year’s Annual Con erence.



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:: PHARMACEUTICALS


Pros and Cons o Alternative Models in Preclinical Studies11:00 am–12:00 pm | Professional Levels: III, IV

Alternatives to whole-animal testing include endpoint assays, cell andtissue cultures, the use o tissue slices, toxicokinetic modeling andstructure-activity relationships and databases. Concordance betweenresults rom alternative tests and those rom animals is an importantissue in protecting public sa ety. Led by preclinical research specialistAlan Stricker-Krongard, PhD, this session will review alternatives and thesteps being taken to ensure these methods can be just as predictive asanimal models, as well as the regulatory implications o using alternativetests.

Quality by Design (QbD): A Framework or Success11:00 am–12:00 pm | Professional Levels: II, III

ICH Guidelines Q8, Q9 and Q10 have provided an avenue or fexibleregulatory approaches to the ling o chemistry, manu acturing andcontrols (CMC) in ormation, in both the initial mar keting application andsubsequent postapproval submissions. The rst o the guidelines took

e ect in 2006 and several phar maceutical manu acturers have utilizedthem in preparing regulatory submissions. In this session led byGerry DiDonato, ScD, you will learn some o the regulatory challenges andopportunities aced by industry to date.

Latin America Regulatory Update1:30–3:00 pm | Professional Levels: I, II, III

Latin America continues to be seen by the pharmaceutical industry asan appealing emerging market, due in part to its interest in outsourcingclinical trials, but also because o the potential or continued uture marketexpansion. This session will give you insight into Latin America’s evolvingregulatory landscape and its agencies. Major processes and requirementswill be discussed so you can walk away with a better understanding o theregulatory opportunities and common challenges in the region.

CDER Executive Sta Briefng3:30–5:00 pm | Professional Levels: I, II, III, IV

Wrought with accomplishment and challenge, 2009 was an event ulyear or FDA’s Center or Drug Evaluation and Research (CDER). A seniorrepresentative will discuss the center’s initiatives and implementationsover the past year during this session, moderated by internationalregulatory expert David Je erys, MD . You will gain insight into CDER plansand priorities or 2010 and hear directly rom CDER on issues that maysigni cantly a ect your company’s regulatory operations.


Recent Advances in Oncology Drug Development8:30–10:00 am | Professional Levels: II, III

New drug and therapeutic biologic cancer treatments and new uses orexisting treatments are developed every year. Regulatory agencies mustbalance the need to ensure the sa ety and e cacy o these promisingmedicines against making them available to the public in a timely manner.In this session led by global regulatory expert Daniel Mannix, PhD, you

will examine the role o regulatory agencies in acilitating the review andaction on promising new cancer therapies, and gain insight into the use o di erent endpoints to support such approvals.

Asia Regulatory Update10:30 am–12:00 pm | Professional Level: II

Over the last decade, Asia has seen continued positive growth, making it astrategic region or development and marketing o medicinal products. Ledby global regulatory expert Munish Mehra, PhD, this session will highlightnational and regional requirements or obtaining permission to conductclinical trials, Good Clinical Practices and ling or approval to placemedicinal products on the market. You will discover current developmentstrategies or China, India and Japan in order to understand the regulatoryenvironment, challenges and opportunities in Asia.

Get the latest in ormation and updates.

Visit RAPS.org/ac2009.

EMEA Executive Sta Briefng10:30 am–12:00 pm | Professional Levels: I, II, III, IV

Outlined in 2005, the EMEA roadmap details the European MedicinesAgency’s ve-year action plan and priority objectives. You will learn howregulatory initiatives in the EU may impact your company or product in this

session moderated by international regulatory expert David Je erys, MD .EMEA representatives will discuss progress on these objectives and otherevents o the past year, including recent activities o the Committee orMedicinal Products or Human Use. Plans and projects being undertaken

or the coming year will also be covered.



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Ensure the health of your career



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REMS: A Real-World Implementation10:30 am–12:00 pm | Professional Levels: II, III

The Food and Drug Administration Amendments Act o 2007 imposedthe requirement or postmarketing Risk Evaluation and MitigationStrategy (REMS) plans or certain products. This legally en orceableobligation places greater burdens on pharmaceutical companies todesign and implement a REMS program that meets FDA standards. Ledby pharmacovigilance expert Rita Cassola, this session will review aREMS plan rom inception through nal implementation or a currentlymarketed product. You will learn some o the important considerations inexecuting an e cient company team e ort and gaining nal acceptanceby FDA. There will be special ocus on certain caveats that warrant specialattention in the REMS.

Improve Supply Chain Management1:30–3:00 pm | Professional Levels: II, III, IV

In this session, you will learn ways to ensur e the quality and integrity o pharmaceutical ingredients with a ocus on auditing suppliers. Supplychain management techniques and trends will be introduced.

Health Canada Executive Sta Briefng3:30–5:00 pm | Professional Levels: I, II, III, IV

Health Canada’s Blueprint for Renewal aims to modernize Canada’sregulatory processes by trans orming its legislative, regulatory and policy

rameworks. In this session led by Canadian regulatory expert PatriciaAnderson, RAC, you will hear rom a senior representative regarding theagency’s progress on this and other key initiatives as well as uture plans.You will gain an understanding o how these changes could impact therequirements when operating within this well-established regulatory regime.

This year you’ll fnd more interactive sessions, moreglobal perspectives and interactive case study sessions

led by experienced regulatory pro essionals.

Global Pediatric Development Programs: Fantasy or Reality?3:30–5:00 pm | Professional Levels: II, III

Although US and EU requirements or pediatric programs are wellestablished, industry is challenged to design programs that provideimportant in ormation about the use o drugs and biologics in childrenwhile meeting the requirements o health authorities and not undulyexposing vulnerable populations to risk. Leading pediatric drug strategistMary Christian, PharmD, will acilitate a panel discussion to review recentexamples o challenges to global programs and explore a path orward.You will be able to provide sound strategic regulator y guidance within yourorganization’s development programs.


Risk/Beneft Presentations That Lead to Drug Approvals8:30–10:00 am | Professional Levels: II, III

Regulatory agencies have expressed a need to improve methodology,transparency, consistency and communication o risk/bene t in ormation

or new drug (or indication) approvals. You will learn how sa ety ande cacy in ormation is provided in NDA s ubmissions, and the di culties

aced by reviewers o that data, in this session led by drug sa ety expertCarrie Corboy, PharmD . Methodologies being developed to address thesedi culties and to standardize presentations in a semi-quantitative way willbe introduced.

Rx-to-OTC Switch8:30–10:00 am | Professional Levels: II, III, IV

Regulatory hurdles or moving a product rom prescription to over-the-counter (OTC) status are stringent, but the switch can o er bothpublic health bene ts and enhanced return on R&D investment or themanu acturer. In this session led by global regulatory and complianceexpert Susan James , industry representatives will explore the uniquechallenges o extending product li ecycle t hrough an Rx-to-OTC switch, withswitch strategies ocusing on decision makers, infuences and processes.

505(b)(2) & Related Applications in the US, EU and Canada10:30 am–12:00 pm | Professional Levels: II, III

Regulatory pro essionals are o ten challenged to nd creative strategiesto get to market aster, obtain product exclusivity and limit the amounto data required or submission. In this session led by drug and deviceregulatory expert Susan Mondabaugh, PhD, you will learn about 505(b)(2)NDA strategies in the US and similar applications in the EU and Canada,including recent trends, challenges and the current regulatory and legalenvironment. You will discover how these strategies may apply to yourcompany’s development programs.

Cardiac Sa ety From Preclinical to Postmarketing

10:30 am–12:00 pm | Professional Level: IICardiac sa ety is still the number one cause or approval process delayor termination by regulatory authorities. It is also the leading cause o market recalls. Led by risk management expert Bernhard Heiles, MD, PhD,this session will teach you about potential cardiac e ects, such as heartmuscle, electrical conduction or oxygen use, and ways to document andinterpret them in light o regulatory requirements or drug development andli ecycle management. The importance o regulatory involvement in broadcardiac sa ety and risk management e orts will be highlighted enablingyou to see the “big-picture” o cardiac sa ety throughout the li ecycle o your product.



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:: Session Leaders:: Speakers

Con erence RegistrationRegistering or the con erence is easy!Simply visit RAPS.org/ac2009. Register by20 August 2009 to save $150 o the RAPSmember rate.

Attending as a group? RAPS o ers adiscount or three or more people attending

rom the same company and registering atthe same time.

More ways to save! RAPS also o ersdiscounted rates or individuals who work or

a government or nonpro t organization andull-time students.

Visit RAPS.org/ac2009 for more information.

Erik Berglund, MD, PhD, RAC, associate managingdirector CRSD, senior regulatory scientist II, CatoResearch

Paul Brooks , vice president and country manager, BSIPS Healthcare

Arthur Caplan, PhD, pro essor, University o Pennsylvania

Sandra Dennis, deputy general counsel, healthcare,Biotechnology Industry Organization (BIO)

Robert Dormer, JD, director, Hyman, Phelps &McNamara PC

Paul Falkenstein, MBA, PhD, vice president, product &port olio processes, Becton Dickinson

Tracey Fox, RAC, regulatory programs manager, GEHealthcare

Axel Hoos, MD, PhD, medical lead, immunology andoncology, Bristol-Myers Squibb International

Virginia Johnson, PhD, vice president, regulatorya airs, Emergent BioSolutions Inc.

Kenneth Kostenbader, MD, head drug sa ety,Americas, Actelion Pharmaceuticals

Raj Kishore, PhD, senior director, EMDPharmaceuticals

Areta Kupchyk, JD, Reed Smith LLPNicole Landreville , regulatory a airs leader, GE

HealthCareDouglas Mead, director, global CMC regulatory a airs,

medical devices and combination products,Johnson & Johnson Pharmaceutical Research &Development LLC

Gillian Miller, PhD, RAC, consultant, SciLucent LLCRhonda Moe, RA/QA consultant, BioReg Technologies

LLCMadoka Murakami, reviewer, O ce o Medical

Devices, Pharmaceuticals and Medical DevicesAgency

Yuzuru Okazaki, PhD, reviewer, O ce o MedicalDevices, Pharmaceuticals and Medical DevicesAgency

Barbara Redman, PhD, RN, dean and pro essor,College o Nursing, Wayne State University

Rosina Robinson, RAC, principal consultant, MedicalDevice Consultants Inc.

Howard Rosen, director, corporate sales, BostonScienti c Inc.

Shiho Tanaka, senior manager, regulatory a airs,Medtronic Japan Co. Ltd.Mya Barbara Thomae, RAC, Regulatory A airs

Consultant, MyraqaRobert Timko, PhD, director, regulatory CMC group,

AstraZeneca LPSatoshi Toyoshima, PhD, director, Center or Product

Evaluation, Pharmaceuticals and Medical DevicesAgency

Hiroshi Yaginuma, specialist or new materials, O ceo Medical Device Evaluation, Ministry o Health,Labour and Wel are

Xin Min Yue, RAC, DVM, regulatory consultant, Eli Lilly& Company

Brigitte Zirger, director, Bureau o Policy, Science andInternational Programs, Health Canada *Denotes session leaders who are speaking

Visit RAPS.org/ac2009 or the most up-to-date list o speakers.

Patricia Anderson, RAC, vice president, regulatoryservices, Canreg Inc.

Karen Bannick McQuoid, principal and ounder, BannickConsulting LLC

Gary Barrett, project manager, KEMA Quality BV*Paul Barry, director, Boston Scienti cEric Berg, director, supplier quality, Amgen Inc.*Sujal Bhalakia , vice president, Becton DickinsonDennis Black, director, e-business, Becton DickinsonScott Bruder, MD, PhD , senior vice president and CTO,

Becton DickinsonBrooke Bumpers, counsel, Hogan & Hartson*Juliet Carrara, RAC , vice president, RA/QA, OptiScan

Biomedical Corp.*Peter Carson , executive vice president, Powell Tate | Weber

ShandwickRita Cassola , associate director, pharmacovigilance,

Canreg Inc.Joy Cavagnaro, PhD, RAC , president and ounder, Access

BIO LLC*Mary Christian, PharmD , director, co-chair Pediatric Drug

Development Committee, Bristol-Myers Squibb*James Cohen, Esq., shareholder, Buchanan Ingersoll &

Rooney*Julia Cooper, PhD, senior director, worldwide head o

medical writing services, Parexel International Ltd.*Carrie Corboy, PharmD, senior director, translational

pharmacovigilance, Johnson & JohnsonGerry DiDonato, ScD , associate director, Bristol-Myers Squibb*William Egan III , executive vice president, global skin care,

Johnson & Johnson Consumer Products Co.*Anita Fenty, RAC, manager, regulatory policy, Covance Inc.*Cindy Fisher, PhD, senior manager, regulatory a airs, Vical

IncorporatedJoyce Frey-Vasconcells, executive director, cells, tissues

and gene therapy, PharmaNet Consulting*Virginia Garcia, RAC, senior regulatory a airs associate,

Davol Inc.*Mark Gordon, MS, RAC, vice president global regulatory

advocacy and policy, Boston Scienti c Inc.Laila Gurney, RAC, director, regulatory a airs, Canada, GE

Healthcare*Bernhard Heiles, MD, PhD , senior director, global

pharmacovigilance & risk management, ShirePharmaceuticals

Nigel Hernandez, PhD, RAC, ounder and president, Centeror the Study o Regulatory A airs*Hal Dayton Hopkins, associate director, quality control,

Abbott LaboratoriesDoug Hunt, senior director, global regulatory a airs, Baxter

HealthcareSusan Jacobs, president, principal consultant, QMS

Consulting Inc.Susan James, vice president, worldwide regulatory a airs,

compliance and quality, GlaxoSmithKline ConsumerHealthcare

David Je erys, MD, senior vice president, Eisai Europe Ltd.Lisa Jenkins, PhD, senior regulatory consultant, Kendle Inc.

James Kelly, PhD, senior director, regulatory a airs, RocheMolecular Systems*

Joel Kent, RAC, manager, quality and regulatory a airs, GEHealthCare*

Robert Klepinski, JD, regulatory attorney, Frederickson &Byron PA

Mark Kramer, RAC, chie strategist/vice president,regulatory a airs, GE Healthcare

Eric Langer, managing partner, BioPlan Associates Inc.*Deborah Lavoie, JD, RAC, director, regulatory a airs

program, GE Healthcare*Daniel Mannix, PhD, group director, oncology, Bristol-Myers

Squibb InternationalMunish Mehra, PhD, managing director, Global Drug

Development Experts LLC *Elaine Messa, RAC, director, medical device quality

systems and compliance practice, Becker &Associates Consulting Inc.*

Gloria S. Miller, RAC , CQA auditor, PPD Inc.Susan Mondabaugh, PhD, vice president, regulatory a airs,

Hurley Consulting Associates Ltd.*Harindranath Nagaradona, PhD , associate director,

pharmaceutical consulting, Kendle Inc.Suzanne O’Shea, JD, counsel, Baker & Daniels LLP*Miriam Provost, PhD, senior consultant medical devices,

Biologics Consulting Group Inc.*Jillian Reed , principal, Reed Technical Associates

Rose Romeo, PhD , executive director, RA/QA, XDx*Nancy Ruth, RAC, director, medical devices, CanReg Inc.*Peter Ruys, PhD, senior regulatory expert, Obelis SA*Robert Schi , PhD, RAC , CEO, Schi & Company Inc.Raymond Seda, MBA, RAC, manager, Latin America,

corporate regulatory a airs, Zimmer Inc.*Adriana Serrão, regulatory a airs director, Latin America,

GE Healthcare–Brazil*William Sietsema, PhD, vice president clinical and

regulatory strategic planning, Kendle International Inc.Mary Speagle, RAC, executive director, Canadian

regulatory a airs, CanReg Inc.*Alan Stricker-Krongard, PhD , chie scienti c o cer,

preclinical services, Charles RiverSara Stults, group director, US pharmaceutical law and

promotion compliance, Bristol-Myers Squibb Co.Yuka Suzuki, PhD, director, O ce o Medical Devices,

Pharmaceuticals and Medical Devices Agency*

Michael Swit, Esq., vice president, The Weinberg Group Inc.*Kyoichi Tadano, PhD , director, International A airs Division,

O ce o Planning and Coordination, Pharmaceuticalsand Medical Devices Agency

Bradley Thompson, MBA, JD, RAC, attorney, EpsteinBecker & Green PC*

Rainer Voelksen, executive, international regulatory a airs,GE HealthCare

Chang-Hong Whitney, MBA, president, Whitney Consulting Ltd.*John Wood, vice president, regulatory a airs, Lithera Inc.Amy Wright, PhD, RAC , principal scientist, CIBA Vision

Corp., Cell Biology*Elisabethann Wright, partner, Hogan & Hartson



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About PhiladelphiaPhiladelphia, a dynamic place where big city excitement meets hometown charm, awaitsyour arrival. Famous as the birthplace of “life, liberty and the pursuit of happiness,” thecradle of liberty offers much more than cobblestone streets and historic landmarks. Cultural,culinary, artistic and ethnic treasures abound in this city and the surrounding countryside.And, of course, the greatest concentration of US history can be found just blocks away atIndependence National Historical Park, including the Liberty Bell and Independence Hall.

Best of all, Philadelphia’s compact downtown provides all of this and much more within ashort walk or cab ride from the Pennsylvania Convention Center and any downtown hotel.

Visit RAPS.org/ac2009 for travel information.



5635 Fishers LaneSuite 550Rockville, MD 20852USA

2009annual conference

&exhibition

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