22 - 24 October, 2019 | Mercure Hotel MOA Berlin, Berlin, Germany

Main Conference Day One

8:30 am - 8:55 am Registration and Coffee

8:55 am - 9:00 am PharmaIQ Welcome

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

Susan Neadle

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

9:10 am - 9:50 am The FDA Regulatory Landscape

  • Discuss the regulation of other combined uses of medical products in the US
  • Address policy developments from pre-market through post market, including topics on pathway availability, key review issues such as bridging and human factors, CGMPs and post market safety reporting
  • Consider regulatory issues relating to combined use products more broadly, including software and technology enabled devices  intended to enable and enhance safe and effective prevention, diagnosis and treatment

John Weiner, Associate Director FDA Office of Combination Products at FDA

John Weiner

Associate Director FDA Office of Combination Products
FDA

9:50 am - 10:20 am Speed Networking

A highlight of Pharma IQ events! Be ready to meet your peers and share best practices. You will have several 2 minute conversations to enable you to introduce yourself to your peers. There is a prize in it for the winner, so, get networking!
Please Share:
1. Who you are
2. The scope of your job role
3. What you plan to achieve from attending this event
4. Your #1 challenge


10:20 am - 10:50 am Networking Coffee Break

10:50 am - 11:30 am MHRA Perspective: Understanding The Regulatory Landscape For Combination Products

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

Dr Stefania Ragone

Pharmaceutical Assessor Licensing Division
MHRA

11:30 am - 12:10 pm Combining MDR regulation requirements and market adoption

  • Hone in on post-MDR peer review evidence throughout your device  lifecycle
  • Improve your study publications from pre-clinical to post-market
  • Create an evidence based strategy throughout the lifecycle of the device thanks to teams cross functional collaboration in order to facilitate market adoption and fulfil MDR requirements
Patrice Becker, Global Director Scientific Communications / Surgical Innovations Medical Affairs at Medtronic

Patrice Becker

Global Director Scientific Communications / Surgical Innovations Medical Affairs
Medtronic

12:10 pm - 1:10 pm Networking Lunch

1:10 pm - 1:50 pm Regulatory Intelligence in Emerging Markets

  • Explore how you can take your combination product beyond the US and EU markets
  • Understand the differing submission requirements for combination products in countries such as China, Malaysia and South Korea
  • Identify the documentation must be submitted in order to remain compliant 
  • Understand how regulatory intelligence can be incorporated into your product and processes

Ola Oyinloye, Associate Director, Medical Devices and Combination Products at AstraZeneca

Ola Oyinloye

Associate Director, Medical Devices and Combination Products
AstraZeneca

1:50 pm - 2:30 pm Regulations: A Notified Body Perspective

  • Analyse the MDR and its impact on medical device manufacturers and the pharmaceutical industry
  • Gain insight into Notified Body interpretations of Article 117 and expectations for manufacturers 
  • Understand the impact of additional Notified Body scrutiny during the conformity assessment 

Julia Frese, Department Manager Centre of Combination Products at TÜV SÜD

Julia Frese

Department Manager Centre of Combination Products
TÜV SÜD

2:30 pm - 3:00 pm Networking Coffee Break

Use this opportunity to benchmark with your peers and identify the key strategies required to optimise your lifecycle management process, from concept to market. Use this 40 min opportunity to discuss your chosen topic and benchmark with your peers.
  • Lifecycle management and registering products across the globe
  • Improving medical device and pharma team collaboration
  • How to structure the regulatory submission 

Milena Roux, Regulatory Professional at Novo Nordisk

Milena Roux

Regulatory Professional
Novo Nordisk

Chris Minnich, Device Project Director at Merck Group

Chris Minnich

Device Project Director
Merck Group

Anja Nielsen, Principal Medical Device RA Professional at Leo Pharma

Anja Nielsen

Principal Medical Device RA Professional
Leo Pharma

3:40 pm - 4:20 pm UK Notified Body: Brexit and EU MDR 2020 Challenges

  • Address the ongoing conformity assessments for new devices/line extensions/manufacturers in application 
  • Look at the future of consultation conducted by UK competent authority for devices with ancillary medicinal substances
  • Cover Notified Body designation, new requirements under the MDR and legacy products
  • Identify best practices for early renewal under MDD to have market access for limited time post May 2020

Tina Amini, Head of Notified Body at Lloyd's Register

Tina Amini

Head of Notified Body
Lloyd's Register

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

Susan Neadle

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

4:30 pm - 4:30 pm Collaberation Mixer