RAPS Atlanta Chapter: Changes Affecting Medical Device Manufacturers— Going From Directive to Regulation in Europe

Come join regulatory professionals from your area for a combination of educational programming, immediately followed by a networking reception at the Westin Atlanta Perimeter North Hotel lounge, located directly next door to the meeting facility.

The new European medical device regulations (MDR) and in vitro diagnostic regulations (IVDR) came into force May 2017, with full implementation deadlines now set for May 2020 and May 2022, respectively. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

This presentation will cover the major changes in the regulatory framework and ways in which device manufacturers are developing plans to meet these changes and to determine the impact on their business.

Join others from your local regulatory community to explore these changes and discuss what it means for manufacturers, regulatory professionals and how you will comply in this ever-changing environment.

This RAPS Atlanta Chapter program is sponsored and hosted by Arbor Pharmaceuticals and is intended to facilitate networking among area regulatory personnel. Light refreshments will be provided during the educational portion of the event, with heavy hors d’oeuvres and non-alcoholic drinks available at the networking reception. RAC holders may claim three RAC recertification credits.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Speaker
  • Registration Info
  • Cancellation

At a Glance

Date:

Thursday, 24 August 2017 (3:00–7:00 pm EDT) 

Location:

Arbor Pharmaceuticals LLC
Six Concourse Parkway, Suite 1800
Atlanta, GA 30328

Directions are available online.

RAC Credits:

3 RAC certification credits upon completion of the program 

Registration Fees:

Prior to 17 August 2017
RAPS Members: $25
List: $40

On or after 17 August 2017
RAPS Members: $35
List: $50

Objectives

At the conclusion of this program, you will have a better understanding of:

  • The changes from current device directive to device regulation
  • What these changes mean for device manufacturers and regulatory professionals
  • How to ensure compliance in this ever-changing environment

    Agenda

    Thursday, 24 August 2017 (3:00–7:00 pm EDT)

    3:00–3:30 pm      Registration, Networking and Refreshments

    3:30–5:00 pm      Speaker Presentation

    5:00–5:30 pm      Interactive Question and Answer Session

    5:30–7:00 pm      Networking Activity at the Westin Hotel

    Speaker

    Tamas Borsai, division manager of non-active medical devices, TÜV SÜD America Inc. 

    Registration Info

    Prior to 17 August 2017
    RAPS Members: $25
    List: $40

    On or after 17 August 2017
    RAPS Members: $35
    List: $50

    >> Registration Online

    >> Registration Form (PDF) – for registration by mail or fax.

    Other Information

    RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

    Questions? Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate. 

    Program Contact

    Local Contact: Melinda Smith, RAPS Atlanta Chapter

    RAPS Contact: Wesley Carr, senior program manager, chapter and volunteer relations, RAPS  

    Cancellation

    Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.