17-20 September 2016, San Jose
  • 2015 RAPS Workshop IconJoin us for a pre-conference warm up. Stretch your learning potential during our one-day and two-day workshops. Each are designed as an opportunity for you to take an extensive, in-depth look into specific regulatory topics, organized by one or more experts with as many as 10 individual presenters. Prepare to fully explore an area of interest and emerge with an advanced skillset and newly developed strategies.

    Single-day workshops can be mixed and matched based on your preference to focus on a specific product area or region. Two-day workshops span Saturday and Sunday to allow in-depth coverage of specific topics or regions. They cannot be combined with the single-day workshop offerings.

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Workshops

  • Saturday, 17 September

    9:00 am–5:00 pm

    Regulatory Strategy Forum for Medical Devices (Two-Day Workshop)

    Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. In this two-day strategic workshop, experts will take you on a guided tour through the process of developing regulatory strategy. You will work in teams and learn how to maximize commercial opportunities for healthcare product manufacturers while minimizing company risk. 

    » Agenda

    Peeling the 510(k) Onion: From Fundamentals to Latest Topics (Two-Day Workshop)

    This interactive, two-day workshop provides a robust baseline in the fundamentals of 510(k) submissions. The latest developments in the 510(k) environment will be reviewed with helpful tips on corresponding optimal regulatory strategy, when and how to contact FDA, and how to optimize opportunities for a predictable 510(k) review experience.

    » Agenda

    Medical Devices in Latin America: Engaging Regulatory Challenges (Two-Day Workshop)

    Our popular two-day 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 key markets are explored in detail. Prior experience completing a US submission (510(k) or PMA) or entrance to the EU is an ideal complement to this workshop. Simultaneous translation offered.

    » Agenda

    EU Regulatory Essentials, Pharmaceuticals and Biologics

    A comprehensive overview of EU regulatory affairs for 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, directives and policies affecting Europe's regulatory system with specific issues and information addressing development considerations, clinical trials, marketing applications, pre- and postmarketing requirements will be covered.

    » Agenda

    US Regulatory Essentials, Medical Devices and IVDs

    A comprehensive overview of US regulatory affairs for devices and IVDs, this workshop will benefit individuals who are new to the regulatory profession, changing product line/industry or preparing for the RAC US examination. Laws and policies affecting US regulation of devices and IVDs; an overview of the agency structures regulating these products; and advertising, labeling and promotional aspects, and postmarket, compliance and enforcement requirements will be covered.

    » Agenda

    Regulatory Leadership Institute (Two-Day Workshop)

    Take the next step in your career with expert-led leadership training with the Regulatory Leadership Institute. Facilitated by professional executive trainers, the Regulatory Leadership Institute immerses you in two fast-paced days of the skills you need to advance your career or step into a leadership role well-equipped and attuned to the challenges ahead.

    » Learn more about the Regulatory Leadership Institute

    Sunday, 18 September

    8:00 am–4:00 pm

    Regulatory Strategy Forum for Medical Devices (Two-Day Workshop)

    Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. In this two-day strategic workshop, experts will take you on a guided tour through the process of developing regulatory strategy. You will work in teams and learn how to maximize commercial opportunities for healthcare product manufacturers while minimizing company risk. 

    » Agenda

    Peeling the 510(k) Onion: From Fundamentals to Latest Topics (Two-Day Workshop)

    This interactive, two-day workshop provides a robust baseline in the fundamentals of 510(k) submissions. The latest developments in the 510(k) environment will be reviewed with helpful tips on corresponding optimal regulatory strategy, when and how to contact FDA, and how to optimize opportunities for a predictable 510(k) review experience.

    » Agenda

    Medical Devices in Latin America: Engaging Regulatory Challenges (Two-Day Workshop)

    Our popular two-day 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 key markets are explored in detail. Prior experience completing a US submission (510(k) or PMA) or entrance to the EU is an ideal complement to this workshop. Simultaneous translation offered.

    » Agenda

    EU Regulatory Essentials, Medical Devices and IVDs: Transitioning From Current Directives Into Future Regulations

    2016 is expected to be the year where the transition begins for medical devices and IVD from the current European Directives to new European Regulations. The Active Implantable Medical Device Directive (AIMDD) and Medical Device Directive (MDD) will merge into the new Medical Device Regulation (MDR). For the IVDs, the In Vitro Diagnostic Directive (IVDD) will be replaced by the In Vitro Diagnostic Regulation (IVDR). This preconference will divide into two tracks. Each track will reconfirm the essentials of the current directives, address the changes introduced by the regulations and provide inputs for planning a successful transition process. Experts will provide attendees with solid understanding of what remains the same, what changes and what are new requirements must be addressed.

    » Agenda

    US Regulatory Essentials, Pharmaceuticals and Biologics

    A comprehensive overview of US regulatory affairs for 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. Laws and policies affecting US regulation of biologics and pharmaceutical products; an overview of the agency structures regulating these products; and advertising, labeling and promotional aspects, and postmarket, compliance and enforcement requirements will be covered.

    » Agenda

    Japan Regulatory Essentials, Medical Devices and IVDs

    Representatives from industry and health authorities (PMDA and MHLW) will help you gain a better understanding of the relevant regulations for marketing medical devices in Japan and the issues to consider when seeking to obtain approval/certification for these devices. 

    » Agenda

    Regulatory Managers Boot Camp

    Looking for a way to improve your communication, management or leadership skills for accelerated professional growth?  Don’t miss this workshop, which will target key topics and practical information you can use to make immediate improvements in your ability to manage people, provide feedback, influence at all levels and lead with or without the title. Interactive case study sessions focus on scenarios you’re likely to face throughout your regulatory career.

    » Agenda

    Regulatory Leadership Institute (Two-Day Workshop)

    Take the next step in your career with expert-led leadership training with the Regulatory Leadership Institute. Facilitated by professional executive trainers, the Regulatory Leadership Institute immerses you in two fast-paced days of the skills you need to advance your career or step into a leadership role well-equipped and attuned to the challenges ahead.

    » Learn more about the Regulatory Leadership Institute