Main Conference Day Two

9:00 AM - 9:30 AM Registration and Coffee

9:30 AM - 9:40 AM Chairman's Opening Address

9:40 AM - 10:10 AM Keynote Address: Harmonising The Integration of Drug Development And Device Approaches

Lori-Ann Woodard, Sr Manager Quality Compliance Combination Products , Teva
  • Establish new trends in Combination Products and their QA requirements
  • Discuss what key process need to be established to harmonise combination product development
  • Evaluate regulatory requirements for submissions, quality assurance and design control
  • Walk through the drug/device development process (new drugs, generics and software)
  • Review the role of Risk Management, Human Factors and Clinical Trials in combination product development

Lori-Ann Woodard

Sr Manager Quality Compliance Combination Products
  • Determine which focus areas should be prioritised amongst the different standards
  • Identify what the different standards represent and where they may be cross over
  • Debate how the different guidelines can coincide with one another

Audrey Clarembeaux

Manager Head of Medical Device Development QA

Helene Gustafsson

Head of Regulatory & Clinical Compliance

11:05 AM - 11:35 AM Coffee Break

11:35 AM - 12:15 PM Navigating The Different Regulatory Guidelines Pathways for Combination Products across the EU and US

Lars Hyveled-Nielsen, Regulatory Project Director Regulatory Affairs & Safety, Zealand Pharma
  • Define the differences and similarities of combinations products between regions
  • Understand the regulatory pathways and how to navigate in the borderline between drugs and devices
  • Learn how the new EU medical device regulation impact combination products regulated as drugs

Lars Hyveled-Nielsen

Regulatory Project Director Regulatory Affairs & Safety
Zealand Pharma

12:10 PM - 12:50 PM Welcome to the Dragon's Lair!

This interactive session packs both fun and games and challenges into a targeted learning session

Delegates and Solution Providerswill split into teams and conceptualise, research and create a brand new product to help with their combination products challenges.
Once formed each idea will be presented to a team of industry expert judges, who will vote on the best idea!

12:50 PM - 1:50 PM Networking Lunch Break

1:40 PM - 3:00 PM Afternoon Symposium: Human Factors Engineering for Combination Products

Heidi Manijeh Mehrzad, Principal Consultant, HFUX Research
The success and value of a Combination Product is directly dependent on the ability of the intended user to safely operate the device as intended by the manufacturer, without inducing harm to themselves and/or others.
This session will dive deeper into giving you a better understanding on the importance of usability and Human Factors in device design, and how to incorporate these considerations throughout the development process

Heidi Manijeh Mehrzad

Principal Consultant
HFUX Research

3:00 PM - 3:30 PM Coffee Break

3:30 PM - 4:10 PM MDR/IVDR Regulation for Medical Devices and Combination Products

Andrew Love, Vice President, Be4ward Ltd
  • Understand the wide ranging regulation change and its implication for Combination Product development
  • Determine the new role of the manufacturer, QP and responsible person in the new guidelines
  • Scrutinise how classification of products has altered and what it means for your device portfolio

Andrew Love

Vice President
Be4ward Ltd

4:10 PM - 4:50 PM How To Compile A Clinical Evaluation for Combination Products

Florian Tolkmitt, Independent Regulatory Affairs and Clinical Evaluation Expert,
  • Discuss the regulatory updates with regards to clinical evaluation for combination products
  • Put together the key factors that need to be considered when compiling a clinical evaluation report
  • Understand the regulation and recommendations that need to be considered for your products

Florian Tolkmitt

Independent Regulatory Affairs and Clinical Evaluation Expert

4:50 PM - 5:00 PM Chairman's closing Remarks