Event Details

At a Glance

Program Dates:
16-17 May 2018

Meeting Location: 
THON Hotel EU
Rue de la Loi 75
Brussels, Belgium

Registration Closes: 9 May 2018

Refund Deadline: 16 April 2018

RAC Credits: 8

Will this meeting be recorded? No

Proof of Attendance: An electronic letter of attendance will be sent upon request

Registration Fees:                          
Prior to 16 April 2018
RAPS Members: $750
Nonmembers: $850
 
17 April – 9 May 2018
RAPS Members: $850
Nonmembers: $950

Seating is limited to 80 people. Advance registration is required. Register early to secure a seat.

Objectives & Audiences

At the conclusion of this program you will be able to:

• Contrast current European top-level regulatory requirements for devices (Active Implantable Medical Device Directive - AIMD, Medical Device Directive – MDD and In Vitro Diagnostics Directive - IVDD) and the new requirements (Medical Device Regulation - MDR and In Vitro Diagnostics Regulation - IVDR)
• Describe how regulatory professionals have implemented the updated requirements
• Identify requirements for transitioning CE marking from the directives to regulations

Who Should Attend

Regulatory affairs staff responsible for Interpreting and leading the implementation of EU medical device regulations, including those responsible for preparing regulatory strategy and detailed execution of preparing technical files and/or conducting clinical evaluations and post market activities. The workshop is ideal for those who need to confirm best practice against current requirements and who are responsible for effectively planning transition to compliance with new regulations. Intermediate level staff.

Agenda

DOWNLOAD HERE

Day One - Wednesday 16 May 2018

08.30 Registration
09.00 Welcome and Introduction to Training Program -- Paul Brooks
09.15 MDR/IVDR Regulations Changes: One Year Later -- Gert Bos, Oliver Bisazza, and Sabina Hoekstra

	MDR Track	IVDR Track
09.45	Clinical requirements	Performance evaluation
10.45	Refreshment break
11.15	Managing legacvy devices (clinical data)	Managing legacy devices (performance evaluation)
12.00	Lunch
13.00	Changes introduced by the new General Safety and Performance Requirements	Changes introduced by the new General Safety and Performance Requirements
14.00	Updating technical documentation and labelling	Updating technical documentation and labelling
15.00	Refreshment break
15.30	Post-market expectations	Post-market expectations
16.30	Roundtable discussions	Roundtable discussions
17.00	Day Close
17.30	Drinks reception Join the RAPS team for an optional post event drink & nibbles to round off day one. Representatives from RAPS European Council will be in attendance and look forward to meeting you.

Day Two - Thursday 17 May 2018

09.00 Recap day one
09.15 Keynote Presentation: Commission representative (including an update on implementing and delegated acts)
10.00 Keynote Discussion: CAMD Roadmap Update
10.45 Q&A EU Commission & CAMD
11.15 Refreshment break
11.45 Notified body perspectives
12.30 Lunch
13.30 Impact on economic operators

	MDR Track	IVDR Track
14.30	Introduction to transition strategies	Introduction to transition strategies
15.00	Refreshment break
15.30	Transition strategies	Transition strategies
16.00	Final Roundtable	Final Roundtable
17.00	Close

Our confirmed panel of experts includes:

• Bassil Akra, PhD, director, Clinical Center of Excellence, TÜV SÜD Product Service GmbH
• Nick Baker, FIBMS, head of IVD Notified Bodies, LRQA (invited)
• Oliver Bisazza, director, regulations & industrial policy, MedTech Europe
• Gert Bos, PhD, FRAPS, executive director and partner, Qserve Group
• Paul Brooks, executive director, Regulatory Affairs Professionals Society
• Erik Hansson, deputy head of unit, DG Health, Consumer Protection, European Commission
• Sabina Hoekstra-van den Bosch, PharmD, FRAPS, lead for European regulation, Philips - Global Regulations & Standards
• Alex Laan, principal certification manager, project manager certification medical devices, DEKRA Certification B.V.
• Niall MacAleenan, deputy director, head of medical devices department, Health Products Regulatory Authority (HPRA)
• Michael Maier, senior partner, Medidee Services SA
• Yvonne Middlefell, RAC FRAPS, executive director, Stellar Regulatory Consulting Ltd.
• Ludger Möller, president, Medical Device Safety Service GmbH
• Rima Padovani, PhD, senior associate, Medidee Services SA
• Makesh Ramalingam, deputy general manager-regulatory, HCL Technologies Ltd
• Sophie Tabutin, PharmD, notified body regulatory lead, BSI
• Luc Van Hove, MD, PhD, ceo, Maraca International Consulting Services
• Rainer Voelksen, FRAPS, vice president, regulatory affairs/quality management, Occlutech
• Anja Wiersma, PhD, ceo, mi-CE Consultancy
• Representatives from European Commission and MHRA (invited)

Cancellations

RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing or by calling customer service by 16 April 2018. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified. 

Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email, to raps@raps.org. 

Substitutions may be accepted with written approval from RAPS by 2 May 2018.