2011 RAPS Workshops
Saturday 22 October–9:00 am–5:00 pm
Sunday 23 October–8:30 am–5:00 pm
Two day workshops: RAC Points 12
One day workshops: RAC Points 6
For the first time, partake in two day workshops. In addition to the Regulatory Strategy Forum for Pharmaceuticals, two popular former one day workshops (The Essentials: US Regulatory Affairs and The Essentials: EU Regulatory Affairs) will span two days, creating an intensive educational experience for those who wish to focus exclusively on US regulatory essentials, EU regulatory essentials, or focus exclusively on device or pharmaceutical essentials. Registrants for these two day workshops will have the opportunity to register for both days for each workshop, or to register for both device-focused or pharmaceutical-focused days across both workshops. For more information email education@raps.org. Regulatory Strategy Forum for Pharmaceuticals (22–23 October)
The Essentials: US Regulatory Affairs (22–23 October)
The Essentials: EU Regulatory Affairs (22–23 October)
Combination Product Regulation in the US Market (23 October)
Regulatory Managers Boot Camp (23 October)
Over the Counter Drugs: Classification, Approval and Compliance, a Practical Review (23 October)
Generics in the US: A Regulatory Primer on Filings and Recent Actions (23 October)
Regulatory Strategy Forum for Pharmaceuticals (22–23 October)
In this highly interactive, hands-on Regulatory Strategy Forum, leading experts from the pharmaceutical and biologics industry will lead you in engaging discussions and interactive case study analysis that will give you the insight and tools you need to develop a successful global regulatory strategy.
In addition to gaining an appreciation for global differences in submission formats and filing strategies and an understanding of the critical importance of monitoring and revising your strategy, you will examine vital regulatory strategy subjects, including regulatory standards, risk management tools and essential elements of a global Regulatory Strategy Document (RSD) and Target Product Profile (TPP).
Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. Successful global regulatory strategies maximize commercial opportunities for healthcare product manufacturers while minimizing company risk. By engaging in in-depth analysis and workgroup collaboration you will gain a thorough understanding of ways to enhance your strategy and further your product’s success.
Workshop Faculty: Alan V. McEmber, MS, RAC, senior director, regulatory affairs, Abbott
Sarah J. Powell, RAC (US and EU), executive director regulatory affairs and writing services, Liquent
Katharine Reinisch, DVM, senior director, regulatory affairs, The Medicines Company » View full agenda
» View faculty bios within the session schedule
The Essentials: US Regulatory Affairs (22–23 October)
A comprehensive overview of the essentials of US regulatory affairs for a range of products including medical devices, biologics and pharmaceuticals, this workshop will benefit individuals who are new to the regulatory profession, changing product line/industry or preparing for the RAC US examination. Regulations and policies affecting US regulation of devices, biologics and pharmaceutical products; an overview of the agency structures regulating these products; as well as advertising, labeling and promotional aspects, postmarket requirements, and compliance and enforcement requirements will be covered.
Workshop Chairs: Elaine Messa, RAC, director, medical device quality systems and compliance practice, Becker & Associates Consulting, Inc.
Alan G. Minsk, JD, partner & chair, Food & Drug Practice Team, Arnall Golden Gregory, LLP » View full agenda
» View faculty bios within the session schedule
The Essentials: EU Regulatory Affairs (22–23 October)
A comprehensive overview of the essentials of EU regulatory affairs for a range of products including medical devices, pharmaceuticals and biologics, this workshop will benefit individuals who are new to the regulatory profession, changing product line/industry or preparing for the RAC EU examination. Regulations, policies and requirements affecting Europe's regulatory system with specific issues and information addressing advanced therapies, clinical trials, marketing applications, pre- and postmarketing requirements, classification, conformity assessment, technical documentation and the Medical Devices Directives will also be covered.
Workshop Chairs: Patricia R. Anderson, RAC (EU), VP regulatory services, OptumInsight formerly CanReg (Drugs and Biologics: Part 1)
Salma Michor, PhD, RAC, founder, Michor Consulting e.U (Drugs and Biologics: Part 1)
Connie O’Connor, project manager, certification medical devices, DEKRA Certification BV
Peter Ruys, PhD, senior regulatory expert, Obelis SA (Medical Devices and IVDs: Part 2) » View full agenda
» View faculty bios within the session schedule
Combination Product Regulation in the US Market (23 October)
Analyze principles and concepts for regulation of combination products. The new guidance documents on chemical action and classification of products as drugs and devices will be discussed and an industry panel will present its views of these guidance documents. Current information on post-approval changes, good manufacturing practices and adverse event reporting for combination products will also be presented. The day will close with a session on obscure combination product issues and another dynamic panel discussion on whether combination product law helps or hinders. Attendees will have opportunities to interact with a representative from FDA’s Office of Combination Products and other esteemed combination product experts.
Workshop Chairs: Suzanne M. O’Shea, JD, counsel, Baker and Daniels, LLP
Bradley Merrill Thompson, MBA, JD, RAC, shareholder, Epstein Becker & Green PC » View full agenda
» View faculty bios within the session schedule
Regulatory Managers Boot Camp (23 October)
If you are looking for a way to improve your communication, management, or leadership skills for accelerated professional growth, you don't want to miss this workshop. Succeeding and advancing in the regulatory profession requires business and leadership skills, as well as regulatory experience. This workshop targets key topics and practical information required to make immediate improvements in your ability to manage people, provide feedback, influence at all levels, and lead with or without the title. Successful seasoned professionals will share their recommendations and strategies during this workshop. This forum will also allow for in-depth discussions with RAPS Fellows and other senior-level regulatory leaders who have served as mentors to many newcomers to the field, navigated through boards of directors, and learned the lessons of managing and leading direct reports, peers, and superiors.
Workshop Chairs: Lisbert Avila-Yu, MBA, MS, RAC, regulatory affairs manager, HeartWare International, Inc.
Peggy J. Berry, MBA, MFA, RAC, vice president, regulatory affairs and quality, Amarin Pharmaceuticals
Joyce Williams, MBA, RAC, FRAPS, principal consultant, ProFocus Regulatory Solutions » View full agenda
» View faculty bios within the session schedule
Over the Counter Drugs: Classification, Approval and Compliance, a Practical Review (23 October)
In an environment that is increasingly risk averse how do you successfully move over-the-counter (OTC) drugs to the US market? As the healthcare community strives for greater access and improved healthcare options, regulatory professionals must be prepared to meet the challenges head-on. Without a thorough understanding of the OTC framework companies lose out on what could be a key component in their regulatory strategy. Attend this workshop for a practical review of OTC drugs including OTC classification, regulation within the US FDA, the monograph process, differences between OTC and dietary supplements and how and what is needed to for registration. In addition to this knowledge base, the workshop will also feature demonstrations on creating a compliant Drug Facts label and filing a Time and Extent Application.
Workshop Chairs: Robert Schiff, PhD, RAC, CQA, FRAPS, CEO & president, Schiff & Company, Inc.
David C. Steinberg, FRAPS, founder, Steinberg & Associates, Inc. » View full agenda
» View faculty bios within the session schedule
Generics in the US: A Regulatory Primer on Filings and Recent Actions (23 October)
This workshop is designed to help the regulatory affairs professional better understand the history behind generics legislation and regulation; the Office of Generic Drugs and their responsibilities; current trends and metrics for generics applications; regulatory strategy for Abbreviated New Drug Applications (ANDA); and current hot topics such as Quality By Design, Complex Generics, Authorized Generics, and Biosimilars. The program will culminate in the preparation of an ANDA.
Workshop Chairs: Vincent Andolina, vice president, Auromedics Pharma LLC
Chand Sishta, PhD, RAC, director, mature products, Global Regulatory Sciences, Bristol-Myers Sq » View full agenda
» View faculty bios within the session schedule
|
|