Data Management and Digitalization in Regulatory Affairs

6.0
RAC Credits
Europe Europe Virtual Programs Virtual Programs
Wednesday, 24 March 2021 (9:00 AM) - Wednesday, 24 March 2021 (5:00 PM) Central European Time (CET)

Data Management and Digitalization in Regulatory Affairs

Agile development, cloud computing, mobile apps, artificial intelligence, cybersecurity — the world has gone digital! Software is increasingly a driving force for the medical devices (MD) industry as well. As regulators tighten the requirements for MDs, trying to maintain oversight over the industry, compliance becomes as even more challenging.

During this one-day workshop, regulators & industry will engage in an open debate aimed at finding common approaches to harmoniously work together. Throughout the first day, questions will be compiled that cannot be easily or immediately answered. These will then be refined and ranked based on audience votes. On the second day, participants will be organized into smaller groups to discuss the questions and formulate possible solutions to share with the rest of the participants.

Guiding Principles

  • We define the topics we want to address together
  • We vote for the topics we find the most interesting
  • We contribute to the topic we find the most intriguing
  • We listen carefully and respect everybody’s opinion
  • We share what we have learned with the entire group

*Please note: This workshop is being held in Central European Time.


Pricing Amounts & Deadlines

24 Nov – 24 Jan 2021:  Early Bird $650 Member | $750 Nonmember

25 Jan – 23 Mar 2021:  Regular $750 Member | $850 Nonmember

Objective

The workshop is an open debate allowing the regulators and industry to exchange themselves and find common approaches for addressing the increasing complexity of the medical devices industry.

Who Should Attend?

  • New regulatory affairs professionals
  • Regulatory affairs professionals with 3 or more years of experience

Agenda

9:00-9:30 Introduction & Background

  • Welcome
  • Short Introduction of the speakers
  • Goals of the workshop
    • Emerging technologies–a review
    • Impact of digitalization on business aspects
    • Handling the increasing complexity by manufacturers
    • Compliance with the regulatory requirements

9:30-12:00 Why do we think a workshop is helpful—from the perspective of:

  • Development Department
  • Data Science
  • Industry
  • Notified Body

12:00-12:30 Lunch Break

12:30-13:00 Wrap up of the morning session & follow up on open questions.

13:00-13:30 Round Table Discussions: Technological insights & formulation of the Software in Agile challenges.

  • How to work Scrum Agile in a regulatory environment
  • Data management—where is my data
  • What are current development trends?
  • Cybersecurity
  • Cloud computing / big data
  • Apps—functional safety
  • AI
  • Regulatory compliance—a retrospective view (Andrei)

13:30-13:40 Short Break

13:40-15:40 Moderated Workshop on how to address the increasing complexity.

15:40-17:00 Presentation of the Results, Sum up & Final Take-Aways


Speakers

Coenraad Davidsdochter

Professional with over 20 years’ experience in software development for the medical sector. Having worked on many aspects as requirements manager, functional designer, test engineer, implementation consultant and product owner, but in the last 10 years mostly on regulatory affairs, quality assurance, information security, GDPR and privacy at BMA and ICT Healthcare Technology Solutions. Graduated in mathematics and philosophy of technology.

 
Christian Glück

Christian Glück

More than 10 years of experience in medical device development as Software Developer, Test Manager and Project Leader. Being lucky enough leading a project and seeing how switching to agile methodologies lead to a world-first product — even in the medical sector. The last two and a half years supporting customers in their agile journey, in various industries.
 

 

Andrei Ninu

Engineer and scientist with 15+ years in the field of medical devices industry, with experience in propelling product development from conception to availability and aftermarket. Graduated in biomechanical engineering with a sound research background. Now, auditor for QM system, software and functional safety specialist with TÜV-Süd PS with an oversight of the current regulatory requirements within the industry.

 

Wicher Visser

IoT Cloud Architect and Data Science Lead with over 10 years in Software Engineering in the security, medical devices and banking industry. Graduated in computer science with a specialization in intelligent systems. Worked as a researcher at the ETH in Zürich, later helped grow a startup company in his role as software developer, project manager, and architect. He currently leads the technology capabilities at ERNI in Switzerland.

 

Cancellation Policy

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. All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

Questions

Call RAPS Solutions Center at +1 301.770.2920, Ext 200.

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