Conference Day Two

8:30 am - 9:00 am Registration and Coffee

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Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

9:10 am - 9:50 am Notified Body’s View on the Implementation of EU MDR’s Article 117

Stephanie Göbel - Quality Manager Medical Device Technology, TÜV SÜD
• Receive an overview on the current regulatory and guidance status related to the Notified Body Opinion according to Article 117 (EU MDR) 
• Hear a Notified Body’s status on the Notified Body Opinion workload  
• Understand a Notified Body’s experiences based on the first assessments related to the Notified Body Opinion
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Stephanie Göbel

Quality Manager Medical Device Technology
TÜV SÜD

9:50 am - 10:30 am Case Study: ISO 20069 Change Management Standard

Amanda Matthews - Sr. Director, Regulatory CMC for Combination Products & Medical Devices, Pfizer
• Be provided with an overview of the standard itself and what it encompasses 
• Consider the standard to ensure effective change management in relation to key aspects for managing change through the product lifecycle
• Review other guidance consideration for change management 

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Amanda Matthews

Sr. Director, Regulatory CMC for Combination Products & Medical Devices
Pfizer

10:30 am - 11:00 am Networking Coffee Break

11:00 am - 11:40 am Case Study: Applying a Platform Approach for Submissions of Combination Products

Manuela Jaeschke - CMC Product Development Director, Abbvie
·         Look at using the same device constituents for different products and understand how this will affect your submissions
·         Discuss the development approach of your products
·         Review the submission approach and be updated on what you can expect

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Manuela Jaeschke

CMC Product Development Director
Abbvie

• Compare the differing regulations of combination products around the globe
• Understand how this might affect your submission process
• Support the product lifecycle of your combination products 

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Ola Oyinloye

Associate Director Medical Devices and Combination Products
AstraZeneca (pending final confirmation)

12:20 pm - 1:00 pm Case Study: Challenges Implementing the Unique Device Identification (UDI)

Jorge Figueira - Quality Manager, Pasante Healthcare
• Discuss the importance of EU UDI verification and validation
• Consider how to approach EU UDI registration
• Understand the EU UDI technical documentation required
• Scrutinise the opportunities for standardisation

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Jorge Figueira

Quality Manager
Pasante Healthcare

1:00 pm - 2:00 pm Networking Lunch

• Hear about recent developments and regulatory planning at FDA for combination products
• Discuss new and pending guidance on pre-market and post-market topics
• Review the regulation of combined use of medical products including software with drugs and combination products

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John Weiner

Associate Director FDA Office of Combination Products
FDA

2:40 pm - 3:20 pm Case Study: Digital Health, Future Innovation and Cybersecurity

Lori-Ann Woodard Archer - Quality Engineering and Compliance Expert and Innovator, UMA Enterprises LLC
·         Understand the roadblocks faced whilst putting connected combination products onto the market
·         Be guided through what needs to be done to successfully launch your connected device
·         Understand the quality system requirements and the worst-case scenario of new device and new drug for NDA submission
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Lori-Ann Woodard Archer

Quality Engineering and Compliance Expert and Innovator
UMA Enterprises LLC

3:20 pm - 4:00 pm Regulatory Considerations during Mobile Medical App Development for Commercial and Clinical Trial Use

Mike Benecky - Senior Director, Global Regulatory Affairs Precision and Digital Medicine, GSK
• Understand why mobile medical apps are defined as medical devices from their intended use shown through labelling claims advertising materials, or oral or written statements
• Discuss how the mobile medical app regulation is health risk-based to balance patient safety and barriers to technological innovation
• Learn why medical device patient risk analysis is a critical activity prior to inclusion of digital tools within clinical trials
• Identify digital safety parameters including patient privacy, data cybersecurity and clinical risk due to app/sensor malfunction

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Mike Benecky

Senior Director, Global Regulatory Affairs Precision and Digital Medicine
GSK

4:00 pm - 4:30 pm Summative Panel Discussion: Offensive Strategy to Embrace Connectivity for Combination Products

Susan Neadle - Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
• What are the opportunities and risks for connected devices?
• Will this affect your go-to-market strategy?
• How should you handle post-market surveillance reporting?

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Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

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Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

4:40 pm - 4:40 pm Networking Coffee Break