RAPS Regulatory Converence Europe 2019

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Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200 or email raps@raps.org if you need to check on the status of your RAPS membership. Email rapseu@raps.org for questions or assistance with registration.

Workshop Details

15 May 2019 - Post-Conference Practical Workshops
 
MDR Workshop – Transitioning to the EU MDR and Managing Legacy Devices

  • The new EU-MDR introduces many changes, including new definitions, reclassifications, new conformity assessment routes, new notified body designations and more. Stricter requirements on safety of ingredients, on clinical evidence and on consistency in regulatory compliance. Much more detailing in the essential principles, and above all: no grandfathering    
  • This training focusses on practical guidance to implement the gaps assessments needed for dossiers, QMS and some specific for clinical. It will provide details on product portfolio review, and on determining the impact of the regulation. High level project planning will be included. The day will be filled with discussions and case-studies.                                                                 
  • Key topics include:
  • Sharing the challenges of getting technical documentation ready for the MDR
  • Particular challenges of considering legacy devices
  • What will notified bodies accept?
  • The workshop is aiming at RA managers, RA directors, QA managers, QA directors, Clinical directors, Marketing managers, Sales Managers, and the international registration department
 
IVDR Workshop – The New EU IVDR Regulatory Paradigm
 
  • The new EU-IVDR is a paradigm shift moving away from largely self-certification to more stringent oversight by notified bodies. Additionally, there is a completely revised rule-based classification system. Enhanced requirements on safety, on clinical performance and clinical utility evidence and on consistency in regulatory compliance is effectively overhauling the system. The availability of notified body reviewers and auditors is limited, and influences company strategies heavily.                                                                                                                                                     
  • This training focusses on practical guidance to implement start building technical dossiers, and a robust QMS. It will support your move from gap assessment towards implementation. High level project planning will be included. The day will be filled with discussions and case-studies.
  • Key topics include:
  • Preparing IVD’s for notified body review
  • What to expect from notified body conformity assessments?
  • Checklist to prepare a plan
  • The workshop is aiming at RA managers, RA directors, QA managers, QA directors, Clinical directors, Marketing managers, Sales Managers, and the international registration department

Workshop Registration Fees*

 

Register by 13 April 2019

Register from 14 April 2019 - 10 May 2019

 

RAPS Member

(€)550

(€)625

Sign in to register

Enterprise Member

(€)525

(€)600

Sign in to register

Government/Regulatory authority

N/A

(N/A

 

Nonmember

(€)650

(€)725

Register
  *You may register for just the post-conference workshops by clicking the appropriate Register button below. If you wish to register for the full conference, please select the appropriate registration category below under Conference Registration Fees. You will be able to add a workshop to your shopping cart.


Conference Registration Fees

13-14 May (All fees in Euros (€); upon check-out registrants will be charged the appropriate value added tax (VAT), based upon location. The VAT for Belgium is 21%.)

 

Register by 13 April 2019

Register from 14 April 2019 - 10 May 2019

 

RAPS Member

(€)1050

(€)1250

Sign in to register

Enterprise Member

(€)950

(€)1100

Sign in to register

Government/Regulatory authority

(€)750

(€)900

Register

Nonmember

(€)1250

(€)1450

Register

Group Rates Available

RAPS offers discounted group rates for those companies which would like to send multiple employees. Inquire within.

Group Rate Inquiry

Register by Mail

Register by Mail

Registration Policies and Procedures

Confirmed Registration:  After going through all steps in the online registration process and providing full payment, you will receive an email that summarizes your purchases and provides other event information. If you do not receive this email confirmation within five business days, email rapseu@raps.org.

Deadlines: You may register online for the conference until 10 May 2019, after which time you will only be able to register at the conference location. 

Payment Types: 

  1. To register online using a credit card (MasterCard and Visa only), please login as appropriate.  If you wish to pay by check, wire or ACH transfer please download the registration form and follow the instructions listed under Method of Payment.  
  2. For payments using check or wire transfers please ensure that you complete a registration form for each registrant as applicable. Failure to do so will delay the processing of your registration for the event especially the post-conference workshops. 

 

Housing and Logistics Details


Radisson Blu, Brussels
Rue du Fosse-aux-Loups 47
B-1000 Brussels Belgium
Tel : +32 (2) 219 28 28
RAPS Room Block- Radisson Blu Brussels

Featuring a modern Art Deco façade that includes a stunning atrium, glass dome and a river designed by renowned architect Michel Jaspers, the Radisson Blu Royal Hotel, Brussels is conveniently located in the city center. It offers easy access to the metro and major rail lines and Central Station is just 500 meters away.  Brussels Airport (BRU) is about 15 kilometers from the hotel and Brussels South Charleroi Airport (CRL) lies about 69 kilometers away. Popular attractions including the Grand Place, Manneken Pis and the BOZAR Museum are just a short walk from the hotel. The hotel’s location in Brussels city center offers guests the opportunity to discover local culture, popular restaurants and bars and trendy shopping streets. From historical charm to gastronomic delights, the city offers something for everyone.

Accommodation
RAPS has negotiated a dedicated room allotment directly at the Radisson Blu hotel that providesbeneficial rates to conference attendees. To obtain this rate, you must book by using the following booking link and using ‘RAPS’ as the promotional code.  Reservations made directly online via the hotel website or any alternative booking service sites will unfortunately not benefit from preferential rates.

Access & Public Transport
The Radisson Blu Brussels is conveniently located in the city center. It offers easy access to the metro and major rail lines and Central Station is just 500 meters away.

Brussels’ Central Station runs both international and national trains and connections directly to Brussels Midi Station: the terminal for Eurostar & Thalys services London (1h25), Paris (1H20) and Amsterdam (1h55) can straightforwardly be reached by foot.

The closest metro station “De Brouckère” can be walked in three minutes and connects to Midi Station as well as the whole underground system of Brussels.

Airports
Brussels airport (BRU) is about 15 kilometers from the hotel and Brussels South Charleroi Airport (CRL) lies about 69 kilometers away.

Train / Bus / Car

Brussels airport

The train is the quickest transportation from Brussels airport to hotel. The Airport Express trains depart every 15 minutes and take only 20 minutes to reach Brussels Central Station (Gare Centrale), which is just a few hundred meters from the hotel property.
Brussels Airport-Zaventem train station is located on level -1 of the terminal, at a small distance from the arrivals hall (2nd floor) and the departures hall (3rd floor).

Brussel-Central: 17 min

Visit Belgian Railway Company SNCB be to consult the schedules or buy a ticket.

To consult the schedules: go to the dedicated Brussels Airport Zaventem station page and click on the orange button to get real-time information.

Brussels South Charleroi Airport
The Brussels City Shuttle is the easiest way to travel from and to the airport to Brussels. The bus times are scheduled to fit in with the flight times and they start running at 3.30am. There is a bus every 30 minutes. To get the best price, you can buy your ticket online in advance. Brussels City Shuttle

From South Station (Gare du Midi - Zuidstation)
From South Station, trams depart every 10 minutes and take only 10 minutes to reach De Brouckère Station or Central Station. Take Tram 3 (direction Esplanade) or Tram 4 (direction Gare du Nord) and disembark at Central Station or De Brouckère. The hotel is a short walk from either station.

Car
The Radisson Blu Royal Hotel can easily be accessed by car. Just follow the signs to the city center and drive towards Cathedrale St.Michel St.Gudule; where a side road turns into Rue du Fossé-aux-Loups. The underground private parking is right after the main entrance. Parking costs: 5€/hour – 35€/day.

Bus and metro options
Guests can travel efficiently throughout Brussels via the metro system. The De Brouckère and Central Station stops are only a few hundred meters away. Another convenient option is the Arenberg public bus, which stops next to the hotel’s main entrance. The concierge can arrange a car, taxi or bicycle for guests. The concierge can also reserve train tickets for both national and international travel.

Private Parking
Underground private parking is available at EUR 35 per day during the week and EUR 20 per day during weekends.

Cancellations and Refunds: 
All requests for cancellations and/or refunds must be received in writing at rapseu@raps.org by 5:00 pm Central European Standard Time on 22 April 2019. All refunds are subject to a 20% assessment. There are no refunds provided if the cancellation date has passed except for medical emergencies. In these cases, supporting documentation will be required in writing and provided by 5:00 PM Central European Standard Time on Friday, 17 May 2019.  Registrants who provide documentation of a serious medical emergency or death of an immediate family member may receive a refund minus a $100 cancellation fee.

Substitutions: No substitutions are allowed and registrations are not transferable.

Meeting Cancellation: RAPS reserves the right to cancel any conference at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.

Agenda/Speakers: Subject to change without notice.  

Photo Release: By registering for this conference, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.  

Data Usage Policy: By registering for this event, I provide consent that my profile will be stored with RAPS and shared with processors for the purpose of doing business with RAPS. I consent to receiving announcements from RAPS and that I can opt-out at any time by contacting RAPS or updating preferences.

I also provide consent to be added to an online community on RAPS Regulatory Exchange at connect.raps.org for networking and related resources and announcements regarding this event.  I may opt out at any time on connect.raps.org.

In addition, I consent to RAPS sharing my profile information to set up an account on the event app and that I may opt out at any time by contacting RAPS.  I am also aware that my name and mailing address will be provided to event exhibitors and that I may opt out of communications with them at any time by directly contacting the exhibitor.

I also hereby understand and agree to the privacy policy provided on RAPS.org.

RAPS Regulatory Conference – Europe 2019 Code of Conduct: RAPS is a welcoming community focused on developing and sustaining a competent global regulatory workforce that drives good regulatory practice and policy to advance public health. We deliver valuable and accessible learning and professional development experiences while empowering regulatory professionals through supportive interactions, relationships and knowledge-sharing.

The RAPS Regulatory Conference offers an innovative and dynamic approach to learning while sparking the creativity of our community. To provide all participants—members and other attendees, speakers, exhibitors, staff and volunteers—the opportunity to benefit, RAPS is committed to providing a positive environment for everyone, regardless of gender, sexual orientation, gender identity, gender expression, disability, physical appearance, ethnicity, religion or other group identity.
 
As regulatory professionals, we have the professional and ethical responsibility to maintain the highest standards of professional conduct and embody the RAPS Code of Ethics in our words, actions and deeds. Consequences for unacceptable behavior may include dismissal from the event.
 
If you witness unacceptable behavior, please contact RAPS staff as soon as possible, either in person or by completing this anonymous form.