2012 RAPS
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RAPS 2012 Session Schedule

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Meeting Schedule

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Wednesday, October 26, 2011
 

08:30 AM to 10:00 AM 		Global Regulatory Environment for Foods with Dietetic and Medical Purposes
Faculty
Manfred Ruthsatz, PHD, RAC, RPH
Vish Prakash
Judy Wood
Track
Health Related Foods

Room: Sagamore 6

Representatives from selected geographies including Europe, Australia/New Zealand and India will discuss the current regulatory environment in these regions with an emphasis on foods with dietetic and medical purposes. Topics include: specificities and product characteristics, regulations, global requirements for product registration and maintenance, reimbursement and strategies for meeting regulatory compliance requirements.

After this session, participants should be able to:
•Describe the specificities and product characteristics of foods with dietetic and medical purposes in different regions
•Discuss current regulation requirements for product registration and maintenance
•Frame strategies for meeting regulatory and compliance issue requirements

Learning Level(s): Intermediate to Advanced
Product Coverage: Health-Related Foods
Geographic Coverage: Global

Session Leader/Speaker:
Manfred Ruthsatz, PhD, RPh, DABT, RAC, head global regulatory affairs & reimbursement, Nestlé Health Science - Nestlé HealthCare Nutrition

Speakers:
V. Prakash, PhD, chair, Panel on Safety of Nutraceuticals and Nutritionals and Functional Foods, FSSAI, Government of India and president, Nutrition Society of India
Judy Wood, Food Standards Australia New Zealand


 

 

 
List Price:  $0.00    Member Price: $0.00
 

08:30 AM to 10:00 AM 		Medical Devices: Case Presentations and Analysis
Faculty
Tracey Fox RAC
regulatory manager, GE Healthcare has more than 14 years of regulatory and quality experience with medicals devices. She is a certified quality engineer and holds an MS in regulatory affairs through San Diego State University. Fox has led Regulatory Affairs Certification (RAC) prep groups and online training programs.

Erik Vollebregt
Track
Medical Devices & IVDs

Room: Sagamore 5

During this session, participants will be presented with cases based on real-life situations with resulting challenges. Participants will have an opportunity to think critically about the issues at hand, interact and contribute to the discussion of the cases in this working session.

After this session, participants should be able to:
• Highlight quality system related issues and other issues in contracts with subcontractors, suppliers or consultants
• Discuss regulation and legal issues concerning medical device software and mobile medical applications regulated as devices
• Determine the boundaries when promoting globally using traditional methods and social media

Learning Level: Intermediate
Product Coverage: Devices
Geographic Coverage: Global with emphasis on EU and US

Session Leader/Speaker:
Erik Vollenbregt, partner, Axon Lawyers

Speaker: 
Tracey Fox, RAC, regulatory programs manager, GE Healthcare


 

 
List Price:  $0.00    Member Price: $0.00
 

08:30 AM to 10:00 AM 		Regulatory Affairs: Partnership and Interaction with Business Colleagues
Faculty
Daniel G. Mannix, PHD
group director, regulatory sciences, Bristol-Myers Squibb International is based at the company's European R&D Headquarters in Braine l'Alleud, Belgium. Previously he was global vice president, regulatory affairs with GE Healthcare (formerly Amersham Health). He has also held a number of regulatory positions with Pharmacia. Mannix holds a PhD from the University of Notre Dame in microbiology and completed an NIH Postdoctoral Fellowship in molecular oncology at The Ohio State University Comprehensive Cancer Center.

Michael J Vivion PhD
is Executive Director of ECG, a global communication consulting company. A former English professor, he has worked in healthcare public relations and regulatory communications: at Roche in Regulatory as Global Head of Strategic Communications. He is visiting lecturer on regulatory communication for the European Centre of Pharmaceutical Medicine. He has helped develop communication strategies and tactics for over 40 drug development and product teams in a wide range of therapeutic areas. He has helped teams preparing for key health authority meetings in the US, Europe, Japan and China. He co-authored several textbooks on rhetoric and collaborated on the 5th edition of S.I. Hayakawa’s Language in Thought and Action (Harcourt Brace Jovanovich).

Olivia Stockard
Stockard, Ph.D., is the president of Stockard-Elmer Company, Inc., a New York-based training and communication consulting firm. She specializes in helping companies design and instruct internal training programs. Dr. Stockard is the author of The Complete Business Writing Kit, Write Right: Insure Your Success, Writing For Accounting Professionals, and The Course Developer’s Handbook. A second edition of her book, The Write Approach: Techniques for Effective Business Writing, was published in June 2011 by Emerald Group Publishing Limited. Dr. Stockard served as Senior Training Manager for Hoffmann-La Roche in the global Regulatory Division. She holds three degrees in English: Ph.D., New York University; M.A., Bryn Mawr College; B.A., magna cum laude, Vanderbilt University.
Track
Regulatory Business

Room: 209

The regulatory professional is central to the business of pharmaceutical development, not only as the primary communicator with health authorities, but also as the one responsible for communicating regulatory concerns and opportunities across all the functions represented on a development team.

For regulatory professionals to deliver this communication leadership, they need to see their unique position within the company, accept the need for a wide variety of advanced communication skills, and establish ways to develop them.

This session will include a discussion of the kinds of skills and behaviors exhibited by an ideal regulatory professional including:
• Job descriptions that make communication roles clear
• Advocating effectively for a point of view 
• Leading fact-oriented people to brainstorm and work in small groups
• Organizing review sessions
• Running or contributing to effective meetings
• Mediating and negotiating
• Managing key messages and issues

After this session, participants should be able to:
• Describe the skills and activities necessary to be effective across functions
• Explain the principles that drive effective communication training and coaching
• Implement changes in communication practices in their own organization

Learning Level(s): Basic to intermediate
Product Coverage: Across all areas
Geographic Coverage: Global

Session Leader/Speaker:
Michael Vivion, PhD, executive director, ECG, Inc.
Presentation Topic: Creating and Preparing for Cross-Functional Communication Opportunities

Speakers:
Olivia Stockard, PhD, president, Stockard-Elmer & Company, Inc.
Presentation Topic: The Role of Training in Developing Effective Regulatory Communicators

Daniel Mannix, PhD, group director, global regulatory strategy, Bristol-Myers Squibb
Presentation Topic: The Genotype and Phenotype of the Regulatory Affairs Professional

 

 

 
List Price:  $0.00    Member Price: $0.00
 

08:30 AM to 10:00 AM 		Speeding Access to Therapeutic Goods
Faculty
Mark A. Ammann PharmD
Ammann is the owner and president of Catalyst Regulatory Services, LLC. Prior to founding Catalyst, Ammann established a successful regulatory affairs consulting practice at United BioSource Corporation where he served as VP of Regulatory Affairs and provided strategic regulatory consulting to a range of clients from start-ups to large multinational corporations. He has over twenty years of experience in the pharmaceutical industry and held positions with increasing levels of responsibility within regulatory affairs at three major pharmaceutical companies (Novartis, Pharmacia and Pfizer). Prior to consulting, Mark held positions including site head for regulatory affairs and quality assurance (Pfizer) and regulatory therapeutic area head for psychiatry (Pfizer and Pharmacia). Amman has experience in numerous TAs including CNS, oncology, dermatology, inflammation, endocrinology and cardiovascular. Ammann received his Doctor of Pharmacy degree from the University of Michigan.

Zareen H. Ahmed
Dr. Ahmed is an associate director in global regulatory affairs at Sanofi. She has over 25 years experience encompassing discovery, development and regulatory affairs in the agrochemical and pharmaceutical industries. Her current responsibilities include developing and implementing global regulatory CMC strategies for NCEs. She holds a Ph.D. in organic chemistry from the University of Pennsylvania.

Christine Hempel
Track
Pharmaceuticals

Room: Sagamore 3

This session will provide an overview of what’s in the regulatory toolbox to accelerate development and approval of new drugs, a case study on the NDA review and approval of  JEVTANA® in just 78 days and a mother’s quest for a drug treatment for Niemann Pick Type C  disease.

After this session, participants should be able to:
•Describe alternative regulatory pathways, including fast track designation, accelerated approval and priority review
•Identify resources and options available, as well as benefits, for development of agents for rare diseases, including orphan designation
•Explain how one company took advantage of a “rolling NDA submission”
•Gather tips on how to efficiently respond to FDA questions during a highly accelerated NDA review
•Demonstrate how a “Compassionate Use” IND can open doors to Phase 2 and 3 clinical trials
•Summarize how a mother with no scientific training found an investigational agent to treat her twin daughters’ rare disease; how she successfully navigated FDA to open an IND and obtain an orphan designation; and develop a clinical protocol for treatment

Learning Level(s): Basic, Intermediate and Advanced
Product Coverage: Drugs
Geographic Coverage: US

Session Leader/Speaker:
Mark A. Ammann, PharmD, president, Catalyst Regulatory Services
Presentation Topic:  What’s in the Regulatory Toolbox to Accelerate Development and Approval of New Drugs? - An Overview

Speakers:     
Zareen Ahmed PhD, associate director, R&D regulatory affairs, Sanofi-aventis
Case Study #1: Road to JEVTANA®: NDA review and approval in just 78 days

Chris Hempel, M.O.M. (Mom On a Mission), patient advocate, Addi & Cassi Fund Regulatory
Case Study #2: A Mother’s Quest for a Drug Treatment – Niemann Pick Type C – a DIY approach to Orphan Designation, IND preparation, Combination Drug/Device development, and more...

 

 

 
List Price:  $0.00    Member Price: $0.00
 

10:00 AM to 10:30 AM 		AM Break
 
List Price:  $0.00    Member Price: $0.00
 

10:30 AM to 12:00 PM 		Horizons Session, Greco Award Presentation and Honorary RAPS Fellow Recognition
Faculty
Susan Alpert, FRAPS
Alpert is currently the principle of SFA Consulting LLC, a one person firm focused on the strategies needed to place medical devices into the global market. Dr. Alpert joined Medtronic in July 2003 as vice president of regulatory affairs and compliance. She was senior vice president, global regulatory affairs at her retirement in May, 2011 and in this role was responsible for all Medtronic global regulatory policy efforts. Prior to joining Medtronic, Alpert served C.R. Bard, Inc., as vice president of regulatory sciences. She also previously worked at FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the director of the Office of Device Evaluation. She is a microbiologist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. Alpert has served on the board of the Food Drug Law Institute (FDLI), a forum for the FDA and the legal, business, academic and consumer communities to exchange perspectives on public policy, law and regulation relating to products subject to FDA jurisdiction. She serves on the board of advisors for the Medical Technology Leadership Forum (MTLF), an educational organization focused on policy makers, the general public, and the media regarding critical issues affecting the development and adoption of advanced medical technology. In addition, Alpert serves on the board of the Women Business Leaders (WBL), an organization of women leaders in the health care sector and on the board of the Minnesota International Center. She is also a past Chair of the Regulatory Affairs Professionals Society and a Fellow in that society. Alpert serves on the Executive Committee of the Clinical Trials Transformation Initiative (CTTI), one of the public/private partnerships working with the FDA to streamline the development of medical products. Alpert completed her undergraduate degree at Barnard College, Columbia University in New York City and holds a master’s degree and PhD in Biomedical Sciences from New York University. She received her medical degree fro the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center in the Bronx, New York and at Children’s National Medical Center in Washington, DC.

Mark A. De Rosch PhD
Robert J. Beall

Room: Hall A

Trends in the global health product sector point toward some key changes including increased focus on personalized products for smaller patient groups and the involvement of patient groups, industry, clinicians, regulators and payers at early stages of product development. These and other factors are prompting the need to reexamine and refine regulatory paradigms.

Expert panelists will use a specific case study as an example of how key changes are already driving the need for new regulatory thinking, how this might be pushed by other patient groups and what it may mean for the general public, and the role of the regulatory profession in shaping and implementing new models.

Speakers:
Susan Alpert, PhD, MD, principle, SFA Consulting LLC
Robert J. Beall, PhD, president and CEO, Cystic Fibrosis Foundation
Mark A. De Rosch, PhD, senior director, regulatory affairs, Vertex Pharmaceuticals Incorporated
David Feigal, MD, MPH, principal, NDA Partners LLC

 

 
List Price:  $0.00    Member Price: $0.00