IVD Regulatory Conference

2019 IVD Regulatory Conference

Are you ready for the changes happening in your IVD Regulatory environment? Seize this unique opportunity to share, learn and connect with your colleagues in the IVD industry. Stay up to date on upcoming and proposed regulatory changes that affect your company’s operations. Learn from industry leaders and network with experts in IVD manufacturing and regulations.

Date: September 25-26, 2019

Location:
Radisson Blu Hotel, Rusland 17
Amsterdam, Netherlands
Phone: +31 20 623 1231

Abstract: During this 2-day conference, international IVD regulatory experts will cover key aspects of upcoming changes to the European regulatory environment, such as IVDR, REACH and BPR. This conference will help you navigate bringing both new and legacy products into compliance, and the impact of the changing regulations on new product development. Regulatory experts will discuss lessons learned and pain points identified when transitioning from IVDD to IVDR.

A particular emphasis of this conference will be on understanding how IVDR and other regulations will affect the raw materials used in IVD manufacturing, including raw materials of high concern such as biocidal products.  We will discuss the current regulatory situation, how to navigate ambiguous cases, and the use of new biocidal products. You will learn about raw materials that are currently included in the REACH Authorization List as well as materials of concern that may be included in the future.

Target Audience:

  • Regulatory Affairs experts
  • In Vitro Diagnostics Devices experts
  • Quality Assurance experts
  • Assay Development Scientists
  • Technology Transfer experts

Registration fees and payment*:
Register before July 21, 2019 for early bird pricing:
2-day technical seminar 400€; breakfast and lunch are included.

Register on or after July 21, 2019:
2-day technical seminar 550€; breakfast and lunch are included.

Hotel reservation:
You may reserve a room at Radisson Blu Hotel at the group rate of 239€ per night. More information on how to make a reservation for this rate will be sent to you with your registration confirmation email.

*Hotel, travel and Visa expenses are at participant’s charge.

Official Invitations:
If you will be requiring an official invitation, please contact:

Matthew Coussens
Product Training Manager
Customer Education and Training
Email: matthew.coussens@milliporesigma.com

For more information, contact:
Katelyn Logan
Product Training Specialist
Customer Education and Training
Email: katelyn.logan@milliporesigma.com

Agenda**


 Day 1, Wednesday, September 25

Start Presentation Title
8:30 AM - 9:00 AM Registration and Check-in
9:00 AM - 9:15 AM Opening Remarks
9:15 AM - 10:00 AM Bringing a legacy product into compliance under IVDR
10:00 AM - 10:45 AM What is required for your IVD quality system
10:45 AM - 11:15 AM Break
11:15 AM - 12:00 PM Bringing a Product into Compliance
12:00 PM - 1:00 PM Lunch
1:00 PM - 1:45 PM Design requirements - changes from IVDD to IVDR- implications for your business
1:45 PM - 2:30 PM Design requirements - changes from IVDD to IVDR- Critical raws/vendor qualifications/ nuts and bolts of materials 
2:30 PM - 3:00 PM Break
3:00 PM - 3:45 PM BPR:  Borderline cases- navigating the grey zones
3:45 PM - 4:30 PM Preservatives - Current Situation
5:00 PM - 7:00 PM Cocktail Hour and Networking 


 Day 2, Thursday, September 26

Start Presentation Title
9:00 AM - 9:45 AM Design Control Considerations for New Products and During Tech Transfer
9:45 AM - 10:30 AM Triton- Case Study - Lessons learned
10:30 AM - 11:00 AM Break
11:00 AM - 12:00 PM REACh – how to identify future challenges 
12:00 PM - 1:00 PM Lunch
1:00 PM - 2:00 PM Microplastic restriction on the horizon 
2:00 PM - 2:30 PM Break
2:30 PM - 3:45 PM Round Table
3:45 PM - 4:15 PM Closing Remarks and Surveys


**Agenda subject to change