2012 RAPS Workshops provide a full day of learning related to specific topics prior to 2012 RAPS. These workshops are developed by program faculty and intended to provide a balance of exposure to principles and concepts, as well as applied learning and information-sharing to give you the opportunity to gain new knowledge, updates on regulations and/or product-specific hot topic issues and take away information beneficial to both you and your organization.
Two popular 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 or 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 and pharmaceutical-focused days across both workshops. For more information email education@raps.org.
Two Day Workshops
CMC Workshop: Key Implications for Regulatory Professionals & Their Role as Business Partners
US Regulatory Essentials
EU Regulatory Essentials
One Day Workshops
Combination Product Regulation in the US Market
Medical Devices in Latin America: Engaging Regulatory Challenges
Regulatory Managers Boot Camp
Strategic Development of Biosimilars
Two Day Workshops
CMC Workshop: Key Implications for Regulatory Professionals & Their Role as Business Partners (26 – 27 October)
Chemistry, Manufacturing and Controls (CMC or Quality) is one of the three key areas (with Safety and Efficacy) that health authorities (HAs) consider for the review and approval of drug applications. Effective CMC strategies and execution may reduce regulatory burden, enable shorter review timelines, and support post-approval maintenance. In addition to demonstrating technical proficiency related to CMC, regulatory professionals must also cultivate strong partnerships with internal and external functional areas in order to achieve their strategic and tactical goals. These partnering functional areas, including business development, operations, product development and product lifecycle management, play an integral role in product development. Regulatory’s ability to understand how these functional areas’ activities interact with and support CMC can have a considerable impact on an organization’s ability to successfully launch a new drug. This program will convey key CMC concepts, challenges and opportunities encountered by those working in regulatory strategy as well as those in functional areas who partner with regulatory to achieve business goals.
Workshop Chair:
David Ziering, PhD, Director, Regulatory CMC, Bristol-Myers Squibb Co.
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US Regulatory Essentials, Pharmaceuticals & Biologics (26 October)
US Regulatory Essentials, Medical Devices & IVDs (27 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:
Day 1: Daniel Bollag, PhD, senior vice president, regulatory and quality, Ariad Pharmaceuticals
Day 2: David Chadwick, PhD, RAC, director, regulatory affairs, regulatory science, Cook Inc.
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EU Regulatory Essentials, Medical Devices & IVDs (26 October)
EU Regulatory Essentials, Pharmaceuticals & Biologics (27 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:
Day 1: Connie O’Connor, project manager, certification medical devices, DEKRA Certification BV
Day 2: Patricia R. Anderson, RAC (EU), VP regulatory services, OptumInsight formerly CanReg
Salma Michor, PhD, RAC, founder, Michor Consulting e.U
Day 1 Agenda >>
Day 2 Agenda >>
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One Day Workshops
Combination Product Regulation in the US Market (27 October)
Analyze principles and concepts for regulation of combination products. The new guidance documents on chemical action and classifications 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 will also be presented. The day will close with a dynamic sessions and panels on obscure combination product Issues and whether combination product law helps or hinders. Attendees will hear directly from a representative from FDA’s Office of Combination Products.
Workshop Chairs:
Suzanne M. O’Shea, JD, counsel, Baker and Daniels, LLP
Bradley Thompson, JD, MBA, RAC, attorney, Epstein Becker & Green PC
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Medical Devices in Latin America: Engaging Regulatory Challenges (27 October)
Continued economic pressures in the US and EU have resulted in medical device companies seeking new market opportunities to remain competitive. Latin American emerging countries, despite the global financial crisis, continue to develop rapidly. This workshop highlights the regulatory processes in Latin America for medical devices and explores how to develop a regional regulatory strategy. Key regulatory differentiators across the region are outlined and Brazil and Mexico, the two largest markets, are explored in detail. Current trends in regulatory oversight, applicability of clinical requirements, cultural aspects and the importance of business partners will be discussed. Interactive case studies provide the opportunity to apply knowledge of developed markets to address the complexity of the Latin American regulatory environment. This workshop is most appropriate for professionals who have already completed a US submission (510(k) or PMA) or entrance to the EU.
Workshop Chairs:
Joel Kent, MS, RAC (US, EU, CAN), manager, quality and regulatory affairs, GE Healthcare
Marcela Saad, president, MarcM Consulting Canada
Raymond Seda, MBA, RAC, associate director, regulatory affairs, Latin America, Zimmer Inc.
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Regulatory Managers Boot Camp (27 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, RAC, CQE, CQA, regulatory affairs manager, HeartWare, Inc.
Peggy Berry, vice president, head of regulatory affairs and quality, Amarin Pharmaceuticals
Joyce H. Williams, RAC, FRAPS, principal consultant, ProFocus Regulatory Solutions
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Strategic Development of Biosimilars (27 October)
Biosimilars is one of the fastest growing industries globally. In fact, analysts expect the global market for biosimilars to grow by more than $3 billion (US) in the next few years (Datamonitor and IMS 2011). This potential demand for biosimilars provides unique opportunities as well as challenges to many biopharmaceutical companies that are struggling to enter this space. The global regulatory landscape is complex, yet navigable. Biosimilar regulations are now in place in most of the major markets and numerous biosimilar guidance documents have been issued by the EMA, including some product specific guidances. FDA issued three biosimilar draft guidances in February 2012. Our talented faculty will provide unique insights based not only on existing regulations and in the major markets but also actual hands-on experience in the biosimilars arena.
Workshop Chair:
Kamali Chance, MPH, PhD, RAC, senior director, global regulatory affairs, Quintiles, Inc.
Agenda >>
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