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2017 RAPS Regulatory Convergence

September 9 @ 08:00 - September 12 @ 17:00 UTC+0

Mapi will participate in RAPS 2017 Regulatory Convergence activities this fall at the Gaylord National Resort & Convention Center in National Harbor, MD. Save the date! Join our experts @ #2017RAPS Sept. 9-12 @ Booth #629 - Contact us with any questions.


The Regulatory Convergence is RAPS’ annual multi-day gathering of the global regulatory community. Attending this event is the perfect opportunity for clients to meet and discuss with some of our experts/specialists.  "Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators - This is where it all comes together."

We invite you to take advantage of this scenario by pre-scheduling an on-site meeting with one or more of our attending experts from Mapi's Strategic Regulatory Services team, during which you can share your needs and ideas with us and we'll offer insights and advice in return: click here to arrange a consultation or email your meeting request to webinquiry@mapigroup.com.

Mapi's Event Role:

Featured Speakers/Session Leaders & Presentations -

Silvia Bendiner - Director, Business Development, Strategic Regulatory Services (SRS) - Latin America, Mapi

  • Panel Discussion Moderator
  • Date/Time: Monday, 11 September 2017  @ 1.15-2.45 pm
  • Topic: "Latin America Regulatory Convergence—Challenges Faced in the Regulations of Biotherapeutic Products" (http://www.raps.org/convergence2.aspx?id=27570#gene)
  • Description: Presently, bio-therapeutic products represent a paradigm to pharmacological innovation, whilst, fulfilling an imperative need to treat diseases which do not count with an adequate, effective treatment option, also providing important benefits to patients. The complexities involved in the elaboration, assessment, and implementation of effective regulations covering the various stages from drug development to finished product manufacturing, most certainly pose challenges to the national Regulatory Authorities across the Latin America region. Join us to learn about the challenges, experiences and best practices faced by the Latin American Regulatory Reference Agencies while implementing the most adequate regulations and procedures helping to ensure patient access to safe, effective and high-quality bio-therapeutic products and related technologies.
  • Full list of speakers/session participants:
    • Silvia Bendiner, director business development and regulatory affairs-Latin America, Mapi Group
    • Javier Guzmán Cruz, director general, National Food and Drug Surveillance Institute, Colombia
    • Rafael Perez Cristiá, head, National Regulatory Agency, Cuba
    • Julio Sánchez y Tépoz, commissioner for sanitary development, COFEPRIS (Mexico)
  • Panel Discussion Moderator
  • Date/Time: Monday, 11 September 2017  @ 4:00 – 5:30 pm
  • Topic: "Global Regulation Changes: Latin America" (http://raps.org/convergence2.aspx?id=27574)
  • Description: Medical devices are essential for the prevention, diagnosis, treatment and rehabilitation of diseases. In the last decades, these products have acquired great relevance across the healthcare sector with associated economic repercussion on a worldwide basis, also becoming relevant to the future of medicine. The national regulatory authorities (NRA) across the Latin American region are responsible for the safety, effectiveness and quality of medical devices, implementing effective and timely controlled regulatory systems in order to guarantee patient access to safe health technologies. Join us to gain insights of the national experiences and regional initiatives across Latin America presented by the key NRAs, in an effort to help strengthen the regulation of medical devices across the Americas. These initiatives have been spearheaded, supported and coordinated in recent years by the PAHO/WHO Collaborating Center for Health Technology Regulation of the CECMED (Cuban National Regulatory Agency) at a regional level.
  • Full list of speakers/session participants:
    • Jarbas Barbosa da Silva Jr., president, National Agency of Health Surveillance, Brazil
    • Silvia Bendiner, director business development and regulatory affairs-Latin America, Mapi Group
    • José Coto, MD, head, Ministry of Health, El Salvador
    • Javier Guzmán Cruz, director general, National Food and Drug Surveillance Institute, Colombia
    • Rafael Perez Cristiá, head, National Regulatory Agency, Cuba

Shirley Furesz, PhD, RAC (Canada) - Associate Director, Regulatory Affairs - Medical Devices, Strategic Regulatory Services, Mapi

  • Session Leader
  • Date/Time: Tuesday, Sep 12, 2017 @ 4:00–5:30 pm
  • Topic: "US Regulatory Landscape for Laboratory Developed Tests (LDTs)" (http://www.raps.org/convergence2.aspx?id=27573)
  • Description: Do you wonder what is happening with the regulation of Laboratory Developed Tests in the US since the FDA draft guidances were published in 2014, a public workshop was held in 2015 and a discussion paper was issued in early 2017? Diagnostic industry and clinical laboratory experts will share their insight on the current status of this area and future prospects for how the regulatory landscape is taking shape.
  • Full list of speakers/session participants:
    • Shirley Furesz, PhD, RAC (Canada), associate director, medical devices, Mapi Group
    • Mark DuVal, JD, FRAPS president, DuVal & Associates PA
    • Steven Gutman, MD, MBA, strategic advisor, Myraqa, Illumina, Inc.
    • Thomas Sparkman, vice president, government relations, ACLA

Roshana Ahmed - Associate Director, Regulatory Affairs - Medical Devices, Strategic Regulatory Services, Mapi

  • Session Leader
  • Date/Time: Monday, Sep 11, 2017 @ 1:15–2:45 pm
  • Topic: "EU MDR and IVDR: Overview" (http://raps.org/convergence2.aspx?id=27574)
  • Description: With the publication of the new EU medical device and IVD regulations, are you prepared to meet the required 2020 compliances? Start planning now by attending this session. Learn the major changes between the Medical Device Directive and regulations, including differences between the proposed and final text. We will highlight timelines for implementation. Find out the Notified Body expectations of manufacturers, expected challenges, timelines, readiness to audit, and impact of Brexit on the CE marking process. Hear industry perspectives on the planning process and unexpected challenges during the transition process. Plus, we’ll discuss the impact on legacy directive products and re-accreditation of legacy product based on postmarket data.
  • Full list of speakers/session participants:
    • Roshana Ahmed, associate director, regulatory affairs, medical devices, Mapi Group
    • Philippe Auclair, PharmD, PhD, FRAPS, senior director, quality and regulatory, EMEA, Abbott Laboratories Inc.
    • Gert Bos, PhD, FRAPS, executive director and partner, Qserve Group
    • Tina Lochner, MS, MBA, president, MEDCERT-USA, LLC

** Please note that this list of speakers/sessions/presentations is subject to change at any time before the conference begins on Sept. 9, 2017 **


Register to attend now:

https://www.raps.org/cr.aspx?id=27018

Details

Start:
September 9 @ 08:00
End:
September 12 @ 17:00
Event Category:
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