29 - 31 October, 2018 | Mercure Hotel Amsterdam City, Amsterdam , Netherlands

Main Conference Day Two

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

9:00 am - 9:10 am Chairperson's Opening Remarks and Welcome

9:05 am - 9:40 am Effective Post Market Maintenance Strategy for Combination Products

Lori-Ann Woodard - Medical Device Director, Lachman Consultants
  • Outlining the considerations for monitoring and maintenance of combination products throughout the entire project lifecycle
  • What are the impacts of regulatory changes, marketing needs or production issues? 
  • The importance of developing technical documentation and supporting processes: What are the key things to include, implementation strategy and potential risks to be aware of?
  • Managing change: Precisely monitoring the change control process based on the documentation

Lori-Ann Woodard

Medical Device Director
Lachman Consultants

  • What are the biggest challenges you are facing currently with developing and managing combination products? 
  • What are the unique characteristics of combination products and how does it impact the design parameters?
  • What are the critical success factors for combination products? What are key requirements and success factors in selecting device manufacturing and design partners?
  • How can different materials influence the design, development and compliance of combination products? 
  • What advice would you give in terms of testing combination products and the critical requirements for essential performance?

Jonathan Kearns

Manager, Device Engineering


Manuela Jaeschke

CMC Product Collaboration Director


Lori-Ann Woodard

Medical Device Director
Lachman Consultants

10:40 am - 11:10 am Morning Coffee and Networking Break

Use this opportunity to discuss key topics with your peers that share similar challenges. Led by our expert facilitators, each roundtable discussion will last for 30 minutes with the opportunity to rotate to a second discussion point.

Roundtable One: Information Management and Design Control to Improving Lifecycle Management 
Facilitator: Margaret Kelly, Device Development Project Leader, Novartis

Roundtable Two: Clinical Evaluations: Challenges, Pitfalls and Solutions
Facilitator: Florian Tolkmitt, Independent Regulatory Affairs and Clinical Evaluation Expert

Margaret Kelly

Device Development Project Leader

Florian Tolkmitt

Regulatory Affairs and Clinical Evaluation Expert
Independent Consultant

12:10 pm - 12:45 pm Safety Assessment Requirements and Strategies for Combination Products

Dr Clemens Günther - Director Nonclinical Safety Consumer Care, Bayer Healthcare Pharmaceuticals
  • Describing the unique characteristics, safety requirements and approaches relating to the assessment of combination products
  • Understanding how the regulatory landscape impacts safety assessments and how to navigate it effectively
  • The importance of early involvement and strategy development
  • Developing a safety assessment and evaluation program: Process, strategy, steps and top tips

Dr Clemens Günther

Director Nonclinical Safety Consumer Care
Bayer Healthcare Pharmaceuticals

12:45 pm - 1:45 pm Lunch and Networking Break

1:45 pm - 2:20 pm An Overview of Human Factors for Combination Products: From Initial Planning Through Reporting

Tina Rees - Associate Director – Human Factors, Ferring Pharmaceuticals
  • Broad overview of human factors: Regulatory considerations and common challenges in the planning, execution, and reporting of human factors
  • Ensuing the safety and effectiveness of human/device compatibility: User interface, instructions and training programs
  • Human factors testing, analysis and validation to identify and eliminate issues
  • Optimising the design of the product to improve usability outcomes

Tina Rees

Associate Director – Human Factors
Ferring Pharmaceuticals

2:20 pm - 2:55 pm Risk Assessment and Risk Management for Combination Products

Bente Post-Pedersen - Program Lead, Biogen
  • Systematic approaches to working with risk management: Establishing full traceability of critical parameters, from the early development phases to the end product being packed and shipped to the end customer
  • Using risk management to develop the control strategy and well documented design transfer of medical devices and combination products
  • Using a quality risk management system as a basis to ensure, monitor and maintain quality throughout the entire product lifecycle
  • Risk-based approaches to design and process validation 
  • Ensuring documentation is clear, transparent and audit-ready

Bente Post-Pedersen

Program Lead

2:55 pm - 3:25 pm Afternoon Coffee and Networking Break

3:25 pm - 4:00 pm Systems Engineering for Combination Products: Enhancing Capabilities

Ettore Marzocchi - Devices Manager I, Device Technology, Novartis
  • Identifying the current challenges relating to combination product devices from a systems engineering perspective
  • Building and implementing device platforms that can be utilised across multiple combination products
  • Enhancing requirements management: implementation of dedicated software for re-use, link and trace requirements across platforms and combination products

Ettore Marzocchi

Devices Manager I, Device Technology

4:00 pm - 4:35 pm Post Market Surveillance and Vigilance of Combination Products

Jonathan Kearns - Manager, Device Engineering, Pfizer
•Defining each term, meaning and relevance
•Ensuring adequate input into the risk management process during product development to identify potential issues
•Developing processes and activities used to continually monitor and evaluate the safety and performance of combination products
•Reporting procedures: Who, what, when and how?

Jonathan Kearns

Manager, Device Engineering

4:35 pm - 4:45 pm Closing Remarks from the Conference Chair and Close of the Conference