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)

Registration Info 

Registration to 16 April 2018
RAPS Members: $750
List: $850
 
17 April– 9 May
RAPS members: $850
List: $950
 
Seating is limited to 80 people. Advance registration is required; no onsite registration is available. Register early to secure a seat.
 
Registration Closes: Early registration (online, mail, and fax) will be accepted until 16 April 2018; registration ends 9 May 2018 unless meeting capacity is reached; after 9 May, please contact RAPS Solutions Center at +1 301 770 2920, ext. 200 or raps@raps.org for registration options.                          
 
Refund Deadline: 16 April 2018
 
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? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact
Wessel Nieuwenweg
wessel@newway-management.com
+33 9 67 62 61 04
 
Hotel Information
Thon Hotel EU
Rue de la Loi 75
B-1040  Brussels, Belgium
Tel: +32 2 204 39 11
 
Located in the European Quarter of Brussels, Thon Hotel EU is your eco-friendly hotel and ideal starting point for both business and leisure travelers. Most of the European Institutions are within easy walking distance and the historical city center is about a stone’s throw away.
 
Accommodation
Due to overwhelming demand for this workshop, rooms with the RAPS special discounted rate at the Thon Hotel EU have been fully booked.

RAPS has researched alternative hotels that are within walking distance of the THON Hotel EU workshop location.  Please utilize the links below to select the best accommodation for your needs:

• Thon Residence
• NH Brussels Berlaymont
• Aloft Brussel Shiman

  You may also utilize booking sites such as Expedia and booking.com to find additional accommodations.

Access & Public Transport
The Thon Hotel EU is located on the Rue de la Loi and just next to Subway stations ‘Maelbeek’, ‘Arts Lois' and ‘Shuman’.

 
Schuman Station is a major HUB and can be reached by Metro (Subway) Line 1 as well as buses 11, 12 and 28.   Alternatively buses 60, 80, 59, 34 stop directly at Place Jourdan-Rue Froissart.
 
For real time information, you can visit the mobile website m.stib.be or download the STIB app for iPhone or Android (available in English).
 
Airport
Brussels Airport is 13 KM from the hotel.
 
Parking
For participants driving to the hotel, the hotel has a private parking facility available (payable).
 
Taxi
Taxis are available directly from the airport upon arrival and participants are encourage to follow the official taxi signage and use officially authorized taxis from the airport.  Two options for taxi companies for travel within the city are: TAXI VERTS (T:  +32 2 349 49 49) or TAXI BLUES (T: +32 2 268 00 00)
 
Airport Bus
The Airport Line is a 30-minute express service between Brussels Airport and the European quarter.  From Monday to Friday until 8 pm the Airport Line is operated as an express service sign posted with number 12 and only serves the major stops (alight at Schuman for Thon Hotel EU). On weekdays after 8 pm, and the whole day on Saturday, Sunday and holidays the Airport Line is operated as a regular service with number 21, serving all stops.
 
All MIVB/STIB buses depart from platform C. In order to save time and money, buy your ticket from the GO ticket vending machines before boarding. These machines accept Maestro bank cards, credit cards and coins. Tickets bought from the driver are more expensive.
 

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.