Pre-Conference Workshops

With Convergence 2020 now live online, the annual preconference workshops have converted to a virtual format too. The workshops now span throughout the months of September and October, allowing you the opportunity to attend all the workshops that matter to you.

Please note that separate registration is required for each workshop and each offers up to 6.0 RAC recertification credits (unless noted otherwise).

 

Compliance With EU MDR General Safety and Performance Requirements (GSPRS) by Application of Standards

1 & 2 September 2020

9 am – 2 pm EDT

Available RAC Credits: 6.0


Participants will learn strategies and tools for substantiation of compliance with the General Safety and Performance Requirements (GSPRs) of the EU Medical Devices Regulation (MDR) Annex I by application of (international) standards.


US Regulatory Essentials, Devices

1 & 2 September 2020

9 am – 2 pm EDT

Available RAC Credits: 6.0


A comprehensive overview of US regulatory affairs for devices and IVDs, this workshop will benefit individuals who are new to the regulatory profession, learning a new product line or industry, or preparing for the RAC Devices exam.

Sharing Experiences for Creation of Sufficient Clinical Data

8 & 9 September 2020

9 am – 2 pm EDT

Available RAC Credits: 6.0


This interactive workshop will focus on two proven clinical strategies for collecting sufficient clinical evidence for currently marketed products. Use of Likert clinical surveys and big data hospital networks are receiving renewed attention and can be used as the primary source of safety and performance data for low-risk devices, or to fill in the gaps for higher risk devices.

Drug Development in EU: Regulatory Standards, Support and New Approaches

9 & 10 September 2020

9 am – 2 pm EDT

Available RAC Credits: 6.0


This workshop will address the various regulatory steps, explain the role of the European regulator not only as being a gatekeeper but also as enabler supporting successful development, marketing authorization and market access.


IVDR: Now Is The Time For Implementation

10 & 11 September 2020

9 am – 2 pm EDT

Available RAC Credits: 12.0


This workshop is aimed at professionals who are already familiar with the EU In Vitro Diagnostics Regulation (IVDR) and are looking to build practical experience. Participants will benefit from working on challenge exercises and hands-on case studies, structured to stimulate discussion and activity on the topic or project.


Bootstrapping Your Regulatory Intelligence: Start And Grow a Successful RI Program from Scratch

17 & 18 September 2020

9 am – 2 pm EDT

Available RAC Credits: 6.0


Attendees will have the opportunity to leveraging the tools and practice the techniques needed to start a regulatory intelligence (RI) program from scratch using simple processes and freely available tools and databases.


Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?

17 & 18 September 2020

9 am – 2 pm EDT

Available RAC Credits: 6.0


This workshop is for the regulatory professional who wants to successfully navigate crucial aspects of human factors and prevent obstacles and risks to your submissions.

EU MDR Annex II Technical Documentation Details: Too Much? Too Little? What Is “Just Right”?

21 & 22 September 2020

9 am – 2 pm EDT

Available RAC Credits: 6.0


The EU Medical Devices Regulation (MDR) will require Medical device manufacturers will need to provide more detailed summary documentation to meet the requirements the EU Medical Devices Regulation (MDR), but how much detail is enough? This workshop will address that common question as speakers and attendees share their experiences.

Pediatric Drug Development - Developing A Successful Strategy Through Case Studies

21 & 22 September 2020

9 am – 2 pm EDT

Available RAC Credits: 6.0


This workshop will engage participants through the development of mock pediatric strategies, pressure testing those strategies with a panel of experts, and identifying regulatory risks and approaches to mitigate those risks.

Advanced Leadership Workshop

1 & 2 October 2020

9 am – 3 pm EDT

Available RAC Credits: 12.0

The Advanced Leadership Workshop immerses participants in two fast-paced days learning and practicing the skills needed to advance your career or step into a leadership role well equipped and attuned to the challenges ahead.

Preparing To Take the RAC Devices

14 & 15 October 2020

9 am – 2 pm EDT

Available RAC Credits: 6.0


Designed specifically for those preparing to take the RAC Devices exam, this workshop focuses on sharpening critical, analytical and strategic test-taking skills. The sessions will be facilitated by a panel of RAC-certified regulatory professionals who are subject matter experts in their fields.