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in the new
regulatory landscape
Now is the time
2009
RAPS
annualconference
&exhibition
13–16 September 2009
Philadelphia
Pennsylvania Convention Center
to Thrive.
decision making throughout the product lifecycle.
Thrive as individuals performing vital work,
making better healthcare products possible.
Connect
Your ability to develop and implement great
ideas depends largely on the depth and breadth
of your network. Being well-connected is not just
about meeting new faces; it’s about bringing
innovative ideas from outside your organization
and putting them to use.
Grow
With over 2,000 regulatory professionals for
you to connect with, learn from and share ideas
with, the 2009 RAPS Annual Conference &
Exhibition, 13–16 September in Philadelphia,
provides you with the power to grow your
network and knowledge base with vital
connections and information that will benefit
you throughout the year.
RAPS.org/ac2009
Connect!
RAPS.org/ac2009 has everything you need to make the most of your Annual Conference
experience. Sign up for the conference Twitter feed, review the list of related products, let
your colleagues know you are attending through the Annual Conference Facebook page,
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
:: Keynote Address
with your conference registration fee?
• S
hare new ideas with colleagues during
Table of Contents
the continental breakfasts, lunches,
refreshment breaks and evening
receptions
Schedule at a Glance............................................................................... 3 Jim Collins
Conference Highlights ............................................................................. 3
• Make potential career connections at the Author of best-selling business book Good to Great and
Career Center co-author of Built to Last, Jim Collins is a renowned expert
Preconference Workshops....................................................................... 5
on enduring great companies––how they grow, how they
• Access 100+ new innovative products in attain superior performance, and how good companies can
Session Descriptions................................................................................ 6
the Exhibit Hall become great companies. He is author or co-author of four
books, and his work has been featured in Fortune, The Wall
• Participate in the new interactive Situation Biologics/Biotechnology................................................................. 6 Street Journal, Business Week, Harvard Business Review and Fast Company.
Rooms featuring hot issue regulatory His most recent book, Good to Great: Why Some Companies Make the Leap
topics facilitated by RAPS Fellows Business.................................................................................... 8 …And Others Don’t, has sold three million hardcover copies and has been
translated into 35 languages.
This is your opportunity to make valuable Clinical............................................................................................ 9
professional connections!
Combination Products.................................................................. 11
Pharmaceuticals........................................................................... 17
Conference Registration......................................................................... 20
Speakers................................................................................................ 20
Session Leaders..................................................................................... 20
The RAPS Business and Leadership
Series equips you with the tools top
About Philadelphia................................................................................. 21
regulatory managers require. Visit
RAPS.org/business to learn more.
* Sponsors confirmed at press time. Visit RAPS.org/ac2009 for the latest list of sponsors.
2
:: Schedule at a Glance
SATURDAY, 12 SEPTEMBER
4:00–7:00 pm Registration, Speaker Ready Room and Bookstore Open
SUNDAY, 13 SEPTEMBER
7:00–8:30 am Continental Breakfast
7:00 am–6:00 pm Registration, Speaker Ready Room, Bookstore and RAPS Information Station Open
8:30 am–5:00 pm Preconference Workshops
10:30–11:00 am Refreshment Break
MONDAY, 14 SEPTEMBER
7:00–8:30 am
7:00 am–5:00 pm
Continental Breakfast
Registration, Speaker Ready Room, Bookstore, Career Center and RAPS Information Station Open
Conference Highlights
8:30–10:00 am Keynote Address & Fellows Induction Annual Celebration Reception
10:00 am–6:00 pm Exhibit Hall Open Get the evening started right! Join your colleagues
10:00–11:00 am Refreshment Break for a night of fun and celebration at RAPS’ largest
11:00 am–12:00 pm Concurrent Educational Sessions social gathering of regulatory professionals.
12:00–1:30 pm Lunch
12:00–1:30 pm Prepare for the RAC Exam
Awards Presentation and Closing Luncheon
12:30–1:15 pm Situation Rooms
Recognize the hard work, dedication, leadership
1:30–3:00 pm Concurrent Educational Sessions
and accomplishments of your colleagues
3:00–3:30 pm Refreshment Break as they are honored for their outstanding
3:30–5:00 pm Concurrent Educational Sessions contributions to the regulatory profession.
5:00–6:00 pm Exhibitors’ Reception
6:30 pm Dine-Arounds
Dine-Arounds
And you thought it was all cheesesteaks
TUESDAY, 15 SEPTEMBER
and pretzels! Many of the best and most
6:15–7:00 am RAPS Foundation 5K Fun-Run
innovative restaurants in the US can be found in
7:30–8:30 am Continental Breakfast
Philadelphia, and within steps of the Pennsylvania
7:30 am–5:00 pm Registration, Speaker Ready Room, Bookstore, Career Center and RAPS Information Station Open Convention Center. Join your colleagues for
8:30–10:00 am Concurrent Educational Sessions spirited conversation over great food and drink.
10:00 am–3:30 pm Exhibit Hall Open
10:00–10:30 am Refreshment Break
10:30 am–12:00 pm Concurrent Educational Sessions
Exhibitors’ Reception
Join your fellow conference attendees and
12:00–1:30 pm Lunch
exhibitors for friendly conversation, food and
12:30–1:15 pm Situation Rooms
drink at this special networking reception––
1:30–3:00 pm Concurrent Educational Sessions
the first big social event of the conference!
3:00–3:30 pm Refreshment Break
3:30–5:00 pm Concurrent Educational Sessions
6:00–8:00 pm RAPS Annual Celebration Reception RAPS Fellows
Engage RAPS Fellows in thought-provoking
WEDNESDAY, 16 SEPTEMBER conversations in the new Situation Rooms and
throughout the conference. Watch the 2009
7:30–8:30 am Continental Breakfast
Class be inducted as new Fellows are recognized
7:30 am–12:00 pm Registration, Speaker Ready Room, Bookstore and RAPS Information Station Open
for their contributions to the profession.
8:30–10:00 am Concurrent Educational Sessions
10:00–10:30 am Refreshment Break
10:30 am–12:00 pm Concurrent Educational Sessions NEW! Situation Rooms
12:00–2:00 pm Closing Luncheon, Keynote Address and Awards Presentation Participate in provocative situation rooms
facilitated by RAPS Fellows that delve
interactively into today’s hottest topics.
3
4
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
:: Preconference Workshops
Register early for one of RAPS’ popular preconference workshops!
Increase your competitive advantage, improve your marketability and Register early for one of these popular preconference
advance your career. If you are new to the regulatory profession, changing
workshops. These programs sell out!
product lines/industry or preparing to take the RAC exam, these programs
will be of great benefit to you. Taught by highly-regarded regulatory
RAPS.org/ac2009
professionals, these workshops cover the latest information in a forum
involving open dialogue between participants and instructors. Join us for a
stimulating learning experience.
5
:: Session Descriptions
TUESDAY, 15 SEPTEMBER
CBER Executive Staff Briefing
8:30–10:00 am | Professional Levels: I, II, III, IV
:: BIOLOGICS/BIOTECHNOLOGY
Global regulatory affairs expert Douglas Hunt will lead FDA’s Center for
Biologic Evaluation and Research (CBER) staff in a discussion about and
MONDAY, 14 SEPTEMBER an update on recent activities and trends, as well as upcoming initiatives
and current developments. You will take home critical information
Gene Therapy: History and Current Status impacting your organization.
11:00 am–12:00 pm | Professional Levels: I, II
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
While curing diseases caused by genetic defects by introducing genetic Submitting a BLA
material into individual cells may offer a significant medical benefit, gene 10:30 am–12:00 pm | Professional Levels: II, III
therapy also has the potential to cause serious harm or even death. As
a result, nearly 20 years after the first demonstration in humans, a gene- Many start-up companies have little or no experience in submitting Biologic
therapy-based product still lacks approval. Senior regulatory manager License Applications (BLAs). FDA regulatory expert and consultant
Cindy Fisher, PhD, will lead the discussion on recent developments from Joyce Frey-Vasconcells and other experienced professionals will discuss the FDA
the Center for Biologics Evaluation and Research’s Office of Cellular, process and offer insights into regulatory strategies and timelines to help you
Tissue and Gene Therapy, to provide you with an understanding of what it meet all requirements for successful, approvable and timely BLA submissions.
takes to conduct clinical research and to develop a gene therapy product
in today’s highly controlled regulatory environment.
Counter-Bioterrorism Agents and the Animal Rule
1:30–3:00 pm | Professional Levels: II, III
Regulatory Models for Biosimilars In this session, William Egan, PhD, and speakers from both government
1:30–3:00 pm | Professional Levels: II, III, IV and industry will address legal and regulatory issues regarding biologics/
In this session, legal expert Michael A. Swit, Esq., will brief participants vaccines and the basics of FDA’s “Animal Rule”—what it can and cannot
on the progress of pending bills in Congress that may provide a statutory do and how it is being implemented in the development of counter-
path for biosimilars as the 1984 Hatch-Waxman Act did for drugs. The bioterrorism biological agents.
European regulatory system’s approach to generic biologics will also be
reviewed; and comparability and techniques for proving bioequivalence
with products that appear similar, but present significant variations in Biopharmaceutical Preclinical Safety Evaluation: The Case-by-Case Approach
immunogenicity will be discussed. You will be able to give your company 3:30–5:00 pm | Professional Levels: II, III
a better understanding of how the new model for generic biologics may To safely introduce novel therapies into clinical trials, preclinical safety
differ from the small molecule model, and how that will create a different evaluation programs for biopharmaceuticals are customized based upon
market for these products. specific product attributes (i.e., the case-by-case approach) and enhanced
utilizing experience with similar products. In this session, toxicology expert
Joy Cavagnaro, PhD, RAC, will lead current and former FDA regulatory
scientists in a discussion of key considerations for the successful
Visit RAPS.org/ac2009 for the latest and implementation of the “case-by-case” approach and how to better predict
whether programs will be acceptable to regulators. Presentations will address
most complete conference information.
recombinant proteins, monoclonal antibodies, and cell and gene therapies.
6
13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009
7
Grow your network
:: BUSINESS
TUESDAY, 15 SEPTEMBER
Developing Successful Public Communications Strategies
MONDAY, 14 SEPTEMBER 8:30–10:00 am | Professional Levels: II, III
How Marketing and Regulatory Can Work Together Public relations expert Peter Carson will lead this session on how
11:00 am–12:00 pm | Professional Levels: II, III to create effective press releases that integrate a product’s clinical
development plan and enhance the value of the company’s public
Establishing a strong relationship and open communications between
communications program. Tips for addressing public inquiries arising from
regulatory and marketing brings positive business results for healthcare
investor conferences, clinical data releases, and postmarketing safety
product manufacturers. Led by marketing expert Eric Langer, this
issues and principles for how to determine the material nature of sensitive
session will provide an overview of marketing’s responsibilities and goals.
information you are exposed to within a company will be introduced.
Discussions will center on reconciling organizational goals between
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
Finance and Accounting in the Strategic Planning Process Government Affairs and the Regulatory Professional
1:30–3:00 pm | Professional Levels: II, III 3:30–5:00 pm | Professional Levels: II, III
More than support functions, finance and accounting are key components Led by legislative expert Paul Barry, this session will greatly enhance your
of an organization’s success sometimes lightly regarded by regulatory ability to contribute to your company’s implementation of new policies and
professionals involved in the product lifecycle, corporate strategy and regulations. The role of government affairs in evolving regulations and
employee development. This session will address budgets, capital and business practices, individual company/trade group lobbying at the state
cash flow information, elements of investments and return on investment and federal levels and forecasting/tracking of potential legislative actions
(ROI) valuation information to help you increase your business acumen will be addressed.
and leverage your voice in the strategic planning process within your
organization.
8
:: CLINICAL
TUESDAY, 15 SEPTEMBER
Designing Clinical Trials With the Target Product Profile in Mind
MONDAY, 14 SEPTEMBER 10:30 am–12:00 pm | Professional Levels: II, III
New Pregnancy and Lactation Labeling Rule Revisions Placing an emphasis on the final product label early in development can
11:00 am–12:00 pm | Professional Levels: I, II produce significant benefits as you approach commercialization. In this
session led by regulatory expert John Wood, you will learn how to establish
In 2008, FDA proposed major revisions to prescription drug labeling,
a labeling strategy and leverage tools like FDA’s Target Product Profile to
requiring that detailed information be provided about the use of drugs/
streamline development and ensure important commercial messages are
biologics by women who are pregnant, nursing or of childbearing age.
built into the overall process.
Led by regulatory expert Lisa Jenkins, PhD, this session will give you an
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2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
Advance
your career
:: COMBINATION PRODUCTS
WEDNESDAY, 16 SEPTEMBER
Using Postmarket Surveillance Data for Medical Devices
8:30–10:00 am | Professional Levels: II, III
MONDAY, 14 SEPTEMBER
For medical device companies, it is challenging to assess the safety of Tissue Engineered Combination Products—Coordination Is Key
devices with only clinical trial data. This session will make you aware 11:00 am–12:00 pm | Professional Level: II
of special safety review considerations for clinical trials in light of risk
Tissue engineered products often consist of a biologic and a device,
management requirements established by ISO 14971, and strategies for
each of which can potentially be produced by a different company. Led by
integrating postmarket surveillance elements.
tissue expert, Joyce Frey-Vasconcells, this session will present a detailed
analysis of the complexity and critical components of developing a tissue
11
TUESDAY, 15 SEPTEMBER WEDNESDAY, 16 SEPTEMBER
CASE STUDY: Combination Product Regulation in Asia CASE STUDY: FDA’s New Approach to Good Manufacturing Practice
8:30–10:00 am | Professional Levels: II, III Requirements
8:30–10:00 am | Professional Levels: I, II, III
Global regulatory expert Nigel Hernandez, PhD, RAC, will lead
this session addressing current and future regulatory initiatives, Currently, there are no regulations describing or prescribing Good
legislation and requirements for combination products in China and Manufacturing Practices for combination products, and there is
Japan, including the framework and bodies (e.g., China’s SFDA re- recognition within FDA, industry and the legal community that further
registration requirements and type testing requirements and Japan’s regulatory and inspectional clarity and guidance are needed. Led by
PMDA and MHLW), the consultation process and relevant draft regulatory law expert James Cohen, Esq., this session will provide you
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
regulations. Case studies and important elements for combination with an overview of FDA’s proposed rule on CGMPs for combination
products will be discussed, as will ASEAN and the common products, the legal basis and rationale, the implications for device
submission dossier template. and drug companies, case studies on how to meet the requirements,
alternatives to the proposed rule and views on whether FDA’s
approach is the appropriate one for the agency and industry.
12
:: COMPLIANCE AND AUDITS Key Points for GMP-Production Compliance
3:30–5:00 pm | Professional Level: II
Understanding the key requirements of Good Manufacturing Practice
MONDAY, 14 SEPTEMBER (GMP)-production compliance is essential for regulated industry. Led by
compliance expert Robert Schiff, PhD, RAC, this session will cover the
Good Clinical Practice Compliance in Clinical Trials
GMP regulations, documentation requirements, corrective and preventive
11:00 am–12:00 pm | Professional Levels: I, II
action (CAPA) plans, self-examination and internal auditing. Compliance
Individuals from pharmaceutical companies, contract research organizations from the receiving area to the warehouse, staging, manufacturing,
(CROs) and academic institutions involved with the supervision or oversight packaging, shipping and quality control, and areas of FDA inspection focus
of clinical trials will learn the principles and requirements for Good Clinical will be discussed.
Practices (GCPs) in this session led by compliance expert Gloria Miller, RAC.
13
PMDA Update: Future Initiatives and Challenges
:: MEDICAL DEVICES AND IVDS 3:30–5:00 pm | Professional Levels: II, III
In this session, led by Japanese regulatory expert Kyoichi Tadano, PhD, hear
directly from senior officials of Japan’s Pharmaceuticals and Medical Devices
MONDAY, 14 SEPTEMBER Agency about PMDA’s Fiscal 2009–2013 second midterm action and policy
plan. Speakers will outline the second midterm plan and discuss future
The Future of GHTF?
agency directions, as well as PMDA’s current initiatives and challenges for
11:00 am–12:00 pm | Professional Levels: I, II, III, IV
quicker medical device review and more effective lifecycle management.
The Global Harmonization Task Force (GHTF) was established in 1992
in an effort to achieve greater uniformity among national medical device
regulatory systems. In this session led by international regulatory specialist A 2010 Approach to the Medical Devices Directive (MDD)
Rainer Voelksen, you will hear from GHTF representatives on the impact 3:30–5:00 pm | Professional Levels: I, II, III, IV
and benefits of current initiatives for the medical device industry. The
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
Led by medical device expert Gary Barrett, this session will brief you
recently developed guidance on supplier quality and a new guidance on
on various MDD updates that will enter into force in March 2010 and
CAPA, as well as information on new countries using or considering GHTF-
provide you with an update on IVD regulations. MDD changes, including:
type systems when introducing a new regulatory framework, will be covered.
EU expectations and direct effects on manufacturers; changes in labeling
and instructions for use, single use, risk analysis, postmarket surveillance,
clinical and technical files/dossiers and the essential requirements; and
how these changes affect certification will be discussed.
Registration is easy!
Visit RAPS.org/ac2009 for more information
on how to register online, by fax or phone. TUESDAY, 15 SEPTEMBER
FDA Office of IVD Evaluation and Safety Special Topics
8:30–10:00 am | Professional Levels: I, II, III, IV
Common Pitfalls and Best Practices in CLSI Study Design
11:00 am–12:00 pm | Professional Levels: I, II, III, IV The transition of products from an unregulated environment to one with
regulations can provide many unique challenges including analyte specific
Understanding the analytical and clinical study requirements to support a reagents (ASRs), laboratory developed tests (LDTs) and IVD Multivariate
successful IVD submission is key to getting your new product approved. Index Assays (IVDMIAs); closed and open laboratory instrumentation;
In this session led by regulatory expert Juliet Carrara, RAC, you will learn and de novo downclassification. This session led by Rose Romeo, PhD,
about the applicable regulations, guidance and standards and increase will provide examples of such transitions involving products that can now
your ability to provide appropriate guidance to enhance your credibility be viewed as in vitro diagnostic medial devices. Case histories will be
within your organization and with reviewers. Discussions will address how presented for situational analysis of topics ranging from initial planning to
to identify applicable standards; when to do analytical (bench) testing submission planning and overall compliance activities.
versus clinical studies; and examples of successful and failed proposals
for alternatives to Clinical and Laboratory Standards Institute study design.
Emerging Markets: Regulatory Challenges and Considerations
8:30–10:00 am | Professional Levels: II, III
CDRH Executive Staff Briefing
1:30–3:00 pm | Professional Levels: I, II, III, IV With the slow moving market in the West, more companies are looking to
emerging markets to expand sales. Regulations in emerging markets are
In this session led by policy expert Mark Gordon, MS, RAC, you will less mature and present many obstacles to Western businesses
hear a detailed review of the past year at FDA’s Center for Devices hoping to gain entry. This session, led by medical device consultant
and Radiological Health (CDRH) as well as an overview of initiatives, Chang-Hong Whitney, MBA, will focus on the regulations and regulatory
milestones and current trends for the next year. You will hear directly from challenges in the emerging markets of China, Taiwan and South America.
senior-level CDRH and industry professionals and you’ll take home critical
information impacting your organization.
14
13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009
15
Impact the profession
Japan in Focus: Regulations for Medical Devices
10:30 am–12:00 pm | Professional Levels: II, III CASE STUDY: Noncompliance Risks in Labeling, Advertising and
Promotion
This session, led by Japanese regulatory expert Yuka Suzuki, PhD,
3:30–5:00 pm | Professional Levels: I, II
will provide you with information on current regulatory processes and
basic requirements for medical device registration in Japan. In addition, To educate the medical device developers and users about the
regulatory and industry representatives will discuss the current status and standards against which the devices will be evaluated and potential
challenges facing the cooperative Japanese-US effort, Harmonization by risks of noncompliance with labeling, advertising and promotional
Doing (HBD), and its impact on international regulatory harmonization for material review processes, regulatory reviewers should be well-versed
medical devices. on logistics and well-informed about the timing, audience and delivery
mode of the devices. Led by senior regulatory specialist Virginia
Garcia, RAC, this session will provide you with a valuable overview
Unique Device Identification—Requirements and Considerations and demonstrate specific examples of how to communicate with key
10:30 am–12:00 pm | Professional Levels: I, II, III, IV stakeholders to improve the efficiency of the review process.
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
16
:: PHARMACEUTICALS
TUESDAY, 15 SEPTEMBER
Recent Advances in Oncology Drug Development
MONDAY, 14 SEPTEMBER 8:30–10:00 am | Professional Levels: II, III
Pros and Cons of Alternative Models in Preclinical Studies New drug and therapeutic biologic cancer treatments and new uses for
11:00 am–12:00 pm | Professional Levels: III, IV existing treatments are developed every year. Regulatory agencies must
balance the need to ensure the safety and efficacy of these promising
Alternatives to whole-animal testing include endpoint assays, cell and
medicines against making them available to the public in a timely manner.
tissue cultures, the use of tissue slices, toxicokinetic modeling and
In this session led by global regulatory expert Daniel Mannix, PhD, you
structure-activity relationships and databases. Concordance between
will examine the role of regulatory agencies in facilitating the review and
results from alternative tests and those from animals is an important
17
18
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
Ensure
the health of your career
REMS: A Real-World Implementation
10:30 am–12:00 pm | Professional Levels: II, III WEDNESDAY, 16 SEPTEMBER
The Food and Drug Administration Amendments Act of 2007 imposed
the requirement for postmarketing Risk Evaluation and Mitigation Risk/Benefit Presentations That Lead to Drug Approvals
Strategy (REMS) plans for certain products. This legally enforceable 8:30–10:00 am | Professional Levels: II, III
obligation places greater burdens on pharmaceutical companies to Regulatory agencies have expressed a need to improve methodology,
design and implement a REMS program that meets FDA standards. Led transparency, consistency and communication of risk/benefit information
by pharmacovigilance expert Rita Cassola, this session will review a for new drug (or indication) approvals. You will learn how safety and
REMS plan from inception through final implementation for a currently efficacy information is provided in NDA submissions, and the difficulties
marketed product. You will learn some of the important considerations in faced by reviewers of that data, in this session led by drug safety expert
executing an efficient company team effort and gaining final acceptance Carrie Corboy, PharmD. Methodologies being developed to address these
by FDA. There will be special focus on certain caveats that warrant special
19
:: Speakers :: Session Leaders
Erik Berglund, MD, PhD, RAC, associate managing Patricia Anderson, RAC, vice president, regulatory James Kelly, PhD, senior director, regulatory affairs, Roche
director CRSD, senior regulatory scientist II, Cato services, Canreg Inc. Molecular Systems*
Research Karen Bannick McQuoid, principal and founder, Bannick Joel Kent, RAC, manager, quality and regulatory affairs, GE
Paul Brooks, vice president and country manager, BSI Consulting LLC HealthCare*
PS Healthcare Gary Barrett, project manager, KEMA Quality BV* Robert Klepinski, JD, regulatory attorney, Frederickson &
Arthur Caplan, PhD, professor, University of Paul Barry, director, Boston Scientific Byron PA
Pennsylvania Eric Berg, director, supplier quality, Amgen Inc.* Mark Kramer, RAC, chief strategist/vice president,
Sandra Dennis, deputy general counsel, healthcare, Sujal Bhalakia, vice president, Becton Dickinson regulatory affairs, GE Healthcare
Biotechnology Industry Organization (BIO) Dennis Black, director, e-business, Becton Dickinson Eric Langer, managing partner, BioPlan Associates Inc.*
Robert Dormer, JD, director, Hyman, Phelps & Scott Bruder, MD, PhD, senior vice president and CTO, Deborah Lavoie, JD, RAC, director, regulatory affairs
McNamara PC Becton Dickinson program, GE Healthcare*
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
Paul Falkenstein, MBA, PhD, vice president, product & Brooke Bumpers, counsel, Hogan & Hartson* Daniel Mannix, PhD, group director, oncology, Bristol-Myers
portfolio processes, Becton Dickinson Juliet Carrara, RAC, vice president, RA/QA, OptiScan Squibb International
Tracey Fox, RAC, regulatory programs manager, GE Biomedical Corp.* Munish Mehra, PhD, managing director, Global Drug
Healthcare Peter Carson, executive vice president, Powell Tate | Weber Development Experts LLC*
Axel Hoos, MD, PhD, medical lead, immunology and Shandwick Elaine Messa, RAC, director, medical device quality
oncology, Bristol-Myers Squibb International Rita Cassola, associate director, pharmacovigilance, systems and compliance practice, Becker &
Virginia Johnson, PhD, vice president, regulatory Canreg Inc. Associates Consulting Inc.*
affairs, Emergent BioSolutions Inc. Joy Cavagnaro, PhD, RAC, president and founder, Access Gloria S. Miller, RAC, CQA auditor, PPD Inc.
Kenneth Kostenbader, MD, head drug safety, BIO LLC* Susan Mondabaugh, PhD, vice president, regulatory affairs,
Americas, Actelion Pharmaceuticals Mary Christian, PharmD, director, co-chair Pediatric Drug Hurley Consulting Associates Ltd.*
Raj Kishore, PhD, senior director, EMD Development Committee, Bristol-Myers Squibb* Harindranath Nagaradona, PhD, associate director,
Pharmaceuticals James Cohen, Esq., shareholder, Buchanan Ingersoll & pharmaceutical consulting, Kendle Inc.
Areta Kupchyk, JD, Reed Smith LLP Rooney* Suzanne O’Shea, JD, counsel, Baker & Daniels LLP*
Nicole Landreville, regulatory affairs leader, GE Julia Cooper, PhD, senior director, worldwide head of Miriam Provost, PhD, senior consultant medical devices,
HealthCare medical writing services, Parexel International Ltd.* Biologics Consulting Group Inc.*
Conference Registration Douglas Mead, director, global CMC regulatory affairs,
medical devices and combination products,
Carrie Corboy, PharmD, senior director, translational
pharmacovigilance, Johnson & Johnson
Jillian Reed, principal, Reed Technical Associates
Rose Romeo, PhD, executive director, RA/QA, XDx*
Johnson & Johnson Pharmaceutical Research & Gerry DiDonato, ScD, associate director, Bristol-Myers Squibb* Nancy Ruth, RAC, director, medical devices, CanReg Inc.*
Development LLC William Egan III, executive vice president, global skin care, Peter Ruys, PhD, senior regulatory expert, Obelis SA*
Registering for the conference is easy! Gillian Miller, PhD, RAC, consultant, SciLucent LLC Johnson & Johnson Consumer Products Co.* Robert Schiff, PhD, RAC, CEO, Schiff & Company Inc.
Rhonda Moe, RA/QA consultant, BioReg Technologies Anita Fenty, RAC, manager, regulatory policy, Covance Inc.* Raymond Seda, MBA, RAC, manager, Latin America,
Simply visit RAPS.org/ac2009. Register by LLC Cindy Fisher, PhD, senior manager, regulatory affairs, Vical corporate regulatory affairs, Zimmer Inc.*
20 August 2009 to save $150 off the RAPS Madoka Murakami, reviewer, Office of Medical Incorporated Adriana Serrão, regulatory affairs director, Latin America,
member rate. Devices, Pharmaceuticals and Medical Devices Joyce Frey-Vasconcells, executive director, cells, tissues GE Healthcare–Brazil*
Agency and gene therapy, PharmaNet Consulting* William Sietsema, PhD, vice president clinical and
Attending as a group? RAPS offers a Yuzuru Okazaki, PhD, reviewer, Office of Medical Virginia Garcia, RAC, senior regulatory affairs associate, regulatory strategic planning, Kendle International Inc.
Devices, Pharmaceuticals and Medical Devices Davol Inc.* Mary Speagle, RAC, executive director, Canadian
discount for three or more people attending Agency Mark Gordon, MS, RAC, vice president global regulatory regulatory affairs, CanReg Inc.*
from the same company and registering at Barbara Redman, PhD, RN, dean and professor, advocacy and policy, Boston Scientific Inc. Alan Stricker-Krongard, PhD, chief scientific officer,
the same time. College of Nursing, Wayne State University Laila Gurney, RAC, director, regulatory affairs, Canada, GE preclinical services, Charles River
Rosina Robinson, RAC, principal consultant, Medical Healthcare* Sara Stults, group director, US pharmaceutical law and
Device Consultants Inc. Bernhard Heiles, MD, PhD, senior director, global promotion compliance, Bristol-Myers Squibb Co.
More ways to save! RAPS also offers
Howard Rosen, director, corporate sales, Boston pharmacovigilance & risk management, Shire Yuka Suzuki, PhD, director, Office of Medical Devices,
discounted rates for individuals who work for Scientific Inc. Pharmaceuticals Pharmaceuticals and Medical Devices Agency*
a government or nonprofit organization and Shiho Tanaka, senior manager, regulatory affairs, Nigel Hernandez, PhD, RAC, founder and president, Center Michael Swit, Esq., vice president, The Weinberg Group Inc.*
full-time students. Medtronic Japan Co. Ltd. for the Study of Regulatory Affairs* Kyoichi Tadano, PhD, director, International Affairs Division,
Mya Barbara Thomae, RAC, Regulatory Affairs Hal Dayton Hopkins, associate director, quality control, Office of Planning and Coordination, Pharmaceuticals
Consultant, Myraqa Abbott Laboratories and Medical Devices Agency
Robert Timko, PhD, director, regulatory CMC group, Doug Hunt, senior director, global regulatory affairs, Baxter Bradley Thompson, MBA, JD, RAC, attorney, Epstein
Visit RAPS.org/ac2009
AstraZeneca LP Healthcare Becker & Green PC*
Satoshi Toyoshima, PhD, director, Center for Product Susan Jacobs, president, principal consultant, QMS Rainer Voelksen, executive, international regulatory affairs,
Evaluation, Pharmaceuticals and Medical Devices Consulting Inc. GE HealthCare
for more information. Agency
Hiroshi Yaginuma, specialist for new materials, Office
Susan James, vice president, worldwide regulatory affairs,
compliance and quality, GlaxoSmithKline Consumer
Chang-Hong Whitney, MBA, president, Whitney Consulting Ltd.*
John Wood, vice president, regulatory affairs, Lithera Inc.
of Medical Device Evaluation, Ministry of Health, Healthcare Amy Wright, PhD, RAC, principal scientist, CIBA Vision
Labour and Welfare David Jefferys, MD, senior vice president, Eisai Europe Ltd. Corp., Cell Biology*
Xin Min Yue, RAC, DVM, regulatory consultant, Eli Lilly Lisa Jenkins, PhD, senior regulatory consultant, Kendle Inc. Elisabethann Wright, partner, Hogan & Hartson
& Company
Brigitte Zirger, director, Bureau of Policy, Science and
*Denotes session leaders who are speaking
International Programs, Health Canada
21
5635 Fishers Lane
Suite 550
Rockville, MD 20852
USA
2009
RAPS
annualconference
&exhibition
13–16 September 2009
Philadelphia
Pennsylvania Convention Center
RAPS.org/ac2009