Main Conference Day One

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

8:55 AM - 9:00 AM PharmaIQ Welcome

9:00 AM - 9:15 AM Chairman's Opening Address

9:15 AM - 10:00 AM Beyond the Molecule - Optimising Combination Product Development Using the E-Health wave

Stephen Dew, Associate Director Combination Products and Medical Devices, Biogen
  • Discuss how digital health will transform the way we view combination products in patient care
  • Analyse the use of next generation technology in product design to enable new value chains in health data and allow for the personalisation of healthcare
  • Plan for the future now, by implementing a digital health combination product development strategy for you company

Stephen Dew

Associate Director Combination Products and Medical Devices

10:00 AM - 10:30 AM Platform Technologies For Antimicrobial and Potential Next-gen Ophthalmic and Cancer Fighting Drug-Devices

Drew Rogers, Global Director for Healthcare & Medical , Trelleborg Sealing Solutions
  • Attributes of silicone elastomers and gels as matrix for drug-device components
  • Limitations of current drug-device process technologies involving drug powders and coatings
  • A different approach to battling infection: antimicrobial immersion-impregnation case study
  • Beyond antibiotics: liquid-phase API impregnation may provide platform technology for next-gen ophthalmic and cancer fighting drug-devices

Drew Rogers

Global Director for Healthcare & Medical
Trelleborg Sealing Solutions

10:30 AM - 11:00 AM Speed Networking

A highlight at PharmaIQ events and now at the Combination Products Forum for you to get involved in! Be ready to meet your peers and share best practice. You will have several 5 minute conversations to enable you to introduce yourself to your peers and add to your network. There is a prize in it for the winner so get networking!
Get ready to share:
-who you are
-scope of your job role
-what you plan to achieve from attending this forum
-your #1 challenge

11:00 AM - 11:30 AM Coffee Break

11:30 AM - 12:05 PM MHRA Perspective: Understanding The Regulatory Landscape For Combination Products

Dr Stefania Ragone , Pharmaceutical Assessor Licensing Division , MHRA
- Determine the information required and hear insight on what is the agency’s point of view
- Gain understanding of MHRA's definition of a Combination Product
- Discuss guidelines that are being introduced and plan for the future of combination product development

Dr Stefania Ragone

Pharmaceutical Assessor Licensing Division

12:10 PM - 12:50 PM Using Design Control To Aid In The Development Of Combination Products

Margaret Kelly, Device Development Project Leader, Novartis
- Document structure and basic principles that aid in project planning, development, execution and life cycle management
-Integration with production systems/documentation to make Disgn Transfer easier and more robust
-Seperating BUsiness processes from Design Control

Margaret Kelly

Device Development Project Leader

12:50 PM - 1:10 PM Cockpit's Guided Compliance For Medical Device And Combination Product Development

Edwin Schumacher, Managing Partner, Synergio
· This enables teams to dedicate more time to important engineering tasks
· Makes demonstrating system safety and efficacy a fluid part of daily tasks
· Development is guided by regulatory compliant templates for Design Controls, PHA, FMEA and Usability Engineering

Edwin Schumacher

Managing Partner

1:10 PM - 2:10 PM Networking Lunch Break

Use this opportunity to discuss with peers key topics facing the industry lead by our expert facilitators. Each roundtable discussion will last for 30 minutes with the opportunity to rotate to a second discussion point.

1) Harmonise the integration of medical device and drug development

2) Analyse the E-Health digital wave for combination products

3) Technology transfer during lifecycle of Combination Products

4) Inhaler and orally inhaled drug product: medicinal product, medicinal product and medical device or a combination product?

Audrey Clarembeaux

Manager Head of Medical Device Development QA

Helene Gustafsson

Head of Regulatory & Clinical Compliance

Jussi Haikarainen

Sr Development Manager, Pharmaceutical Sciences Platform

Sofia Ribero

Head of Quality for Projects and Technology Transfers

3:10 PM - 3:40 PM Afternoon Tea

3:10 PM - 3:50 PM Optimising and De-risking Device Development of Combination Products

  • Understand how device approaches alter in new mechanisms and drug approaches
  • Discuss the synergistic effects between device mode of actions and drug mode of action and their impacts on development plan
  • Strategise on how digitalisation can support combination product development in light of the e-health wave

3:50 PM - 4:30 PM Applying the TRIZ Methodology to Medical Device Innovations

René Dathe, Head of Quality Medical Devices Shared Function, Novartis
- Discuss how the TRIZ methodology can be utilised to drive product innovation
-Analyse development trends for medical devices and combination products
- Hear how mechanisms and materials innovate product design

René Dathe

Head of Quality Medical Devices Shared Function

4:30 PM - 4:40 PM Chairman's Closing Remarks