2021 PDA Combination Products and the Regulatory Framework Workshop

Dear Colleagues, 

The 2021 PDA Combination Products and the Regulatory Framework Workshop will be taking a novel approach to a familiar topic! During the past workshops, the application of MDR article 117 was intensively discussed and strategies have been laid out on how to best address the numerous open regulatory hurdles. Now, we are well into the implementation of the MDR, and first hands-on experience has been gathered on what it means to get a notified body opinion for the device part of your combination product.

Therefore, we would like to take the opportunity to peek into real-life industry case studies and applications. The involved parties (manufacturers, marketing authorization holders and notified bodies) have embarked on a joint journey to minimize risks to the patient. Also, the efforts on both sides should be efficiently reduced by establishing a pragmatic approach, especially when regulatory guidance is still sparse.

We invite you to hear the latest lessons learned and best practice approaches from industry and regulatory bodies on getting a notified body opinion and on the impact of use errors and risk management. Get involved with your own experience and exchange your thoughts on the current challenges around MDR 117 and understand the target of a Notified Body Opinion. 

In order to maximize the benefit of this workshop we would like the attendees to participate actively in interactive live video group discussions and practical exercises, involving the simulated application of combination products. This enables the participants and speakers to go through the major potential roadblocks that need to be addressed for a good baseline and further exchange with the parties involved and thereby generate practical take-home messages for all participants.

We look forward to welcoming you online!

Sincerely,  

The Workshop Lead,  

Egmont Semmler, TÜV Süd 

WORKSHOP COMMITTEE:
Egmont Semmler, TÜV Süd
Stephanie Göbel, Beyond Conception
Michael Karl Ledinegg, Sandoz - Novartis
Mike Wallenstein, Novartis

Upon participation of this workshop you will be able to: 

• Learn how real device applications for a Notified Body Opinion were handled by Notified Bodies and what the lessons learned are for all parties.
• Understand the most common misunderstandings between the risk mitigation processes from Pharma Industry side versus the Notified Body perspective.
• Learn to identify the regulatory gaps from the already existing drug device information to the requirements of the Notified Bodies (e.g. device usability, functional safety, risk management) and gain insights on how to adapt your internal processes.
• Understand what a Notified Body Opinion is and what are the key elements to be addressed, such as e.g. usability, functional safety aspects, patient population considerations in risk control or design change management.