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

Main Conference Day One

8:15 am - 8:50 am Registration and Coffee

8:50 am - 9:00 am PharmaIQ Welcome

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

9:10 am - 9:45 am Global Trends and the US FDA Regulatory Landscape

Viky Verna - Co-Founder and Vice President confinis
  • Global snapshot of the regulatory landscape: Challenges and future trends
  • A comprehensive overview of the US FDA regulation for combination products: How has it evolved and will it change in the future?
  • Reviewing the drug and-device regulation within the US market and how it applies to combination products
  • Recommendations for drug-device manufacturers developing, launching and marketing combination products

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Viky Verna

Co-Founder and Vice President
confinis

9:50 am - 10:20 am Implementing the New Requirements for EU MDR Combination Products

Tina Amini - Senior Technical Specialist Lloyds Register
  • What has been the impact of EU MDR on combination products?
  • Developing an effective regulatory strategy to navigate the complexities
  • Availability of guidance documents for additional support
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Tina Amini

Senior Technical Specialist
Lloyds Register

10:20 am - 10:55 am Exploring the Similarities and Differences between the US and European Markets

Steve Dew - Associate Director Combination Products and Medical Devices Biogen
  • EU vs. US regulatory landscape: Exploring and defining the key differences, similarities and subsequent impacts on each region
  • Understand the regulatory pathways and how to successfully navigate between drugs and devices
  • Learn how the new EU medical device regulation impacts combination products regulated as drugs
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Steve Dew

Associate Director Combination Products and Medical Devices
Biogen

10:55 am - 11:25 am Morning Coffee and Networking

  • Understanding how combination products are defined and classified globally: EU, US and Asia
  • Making sense of the regulatory contradictions and focusing on the specific requirements within the EU?
  • Gaining a deeper understanding of the roles of Competent Authorities and Notified Bodies
  • Post Brexit impacts on drug device combination product regulations
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Heidi Horsch

Head of Corporate Strategy
confinis

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Susan Neadle

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

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Steve Dew

Associate Director Combination Products and Medical Devices
Biogen

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Tina Amini

Senior Technical Specialist
Lloyds Register

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Viky Verna

Co-Founder and Vice President
confinis

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Johannes Keuschnigg

Senior Manager, Regulatory & Medical Device
Sandoz

12:25 pm - 1:00 pm Post Market Safety Reporting for Combination Products: Implementation Challenges and Proposed Solutions

Khaudeja Bano - Head of Medical Affairs Abbott Molecular
  • What is Post Market Safety Reporting: Streamlining and reducing unnecessary reporting and improving the quality of reports
  • What are the biggest challenges associated with ensuring compliance? 
  • What are the unique reporting requirements? 
  • Guidance on how to comply with the final rule: Effectively planning to adequately address adverse events
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Khaudeja Bano

Head of Medical Affairs
Abbott Molecular

1:00 pm - 2:00 pm Lunch and Networking Break

2:00 pm - 2:35 pm Case Study: Developing a Project Roadmap for Combination Products: From Clinical Device to the Marketed Product

Udo Stauder - Global Device Project Leader Sanofi
  • General review  of the different combination products currently in the market
  • Common challenges associated with the development, submission and worldwide launches of a new drug delivery devices
  • Risk and regulatory compliance planning
  • Project management: Best practice scope definition, design co-ordination, management and launch
  • Establishing an on-going post market surveillance strategy to monitor and identify potential improvement areas
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Udo Stauder

Global Device Project Leader
Sanofi

  • The importance of understanding customers requirements, the types of products they use and the associated quality issues 
  • Developing robust product and process design approaches along with an individual management strategy for each product type
  • Best practice  life-cycle management methodologies that can be used to improve patient centricity through high quality products

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Susan Neadle

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

3:10 pm - 3:40 pm Afternoon Coffee and Networking Break

3:40 pm - 4:15 pm Compiling a Comprehensive Clinical Evaluation Plan

Florian Tolkmitt - Regulatory Affairs and Clinical Evaluation Expert Independent Consultant
  • Reviewing the regulatory landscape and how it applies to clinical evaluations for combination products: Recent developments and regulatory strategy
  • Describing the clinical evaluation process and consultation procedures
  • Key considerations for compiling a Clinical Evaluation Assessment report
  • Summary of the Safety and Clinical Performance requirements: Recommendations for combination products

Florian Tolkmitt

Regulatory Affairs and Clinical Evaluation Expert
Independent Consultant

4:15 pm - 4:50 pm A Biosimilars Perspective on Combination Product Development and Registration

Johannes Keuschnigg - Senior Manager, Regulatory & Medical Device Sandoz
  • What points do biosimilar companies have to consider while following the design control process
  • Developing a regulatory strategy leading to fast approvals
  • Experience from recent EMA and FDA reviews of combination products
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Johannes Keuschnigg

Senior Manager, Regulatory & Medical Device
Sandoz

4:55 pm - 5:00 pm Closing Remarks from the Conference Chair and End of Conference Day One

5:00 pm - 6:00 pm Networking Drinks Reception