Combination Products Forum


Berlin, Germany

Covering End-to-end Lifecycle Management Through a 100% Interactive Programme

The 3rd Annual Combination Products Forum 2019 will focus on the entire product lifecycle management process: From planning, design and implementation, right the way through to post-market maintenance and surveillance strategies.

Through a range of interactive workshops, panel discussions, roundtables and case study presentations, key topics will focus on device development, navigating the regulatory landscape, the EU MDR 2020, change management and departmental alignment, product usability, human factors, post-market surveillance and general management across the total product lifecycle becoming critical.

Split across three days, the event will focus on one key question: Can you successfully launch and manage a combination product?

Benefits of Attending:

  • Understand How to successfully navigate the complex and confusing regulatory landscape at a global level
  • Develop Internal procedures and change management strategy that will align drug-device departments and partners
  • Implement An effective combination product strategy from initial planning, design, assessment through to post-market maintenance
  • Launch Your combination product.


"Extremely valuable, lots of take aways"
Senior Manager Software Validation, Biotronik

"It was very interesting, a lot of information to digest, many people with exceptional experience, new trend on the industry. Very good overall!"
Medical Software Validation Manager, Teva Pharmaceuticals

"The event was really effective, both as talks and as networking"
Director of QA and Regulatory Affairs, Systelab Technologies

Meet Our Expert Speakers and Facilitators Include:

  • Susan Neadle, Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
  • John Weiner, Associate Director FDA Office of Combination Products, FDA
  • Tina Amini, Head of Notified Body, Lloyd's Register
  • Dr Stefania Ragone, Pharmaceutical Assessor Licensing Division, MHRA
  • Khaudeja Bano, Head of Medical Affairs, Abbott Molecular
  • Jane Wilson, Product Safety Manager, Owen Mumford
  • Kirsten Paulson, Sr. Director, Global CMC-Medical Device Lead, Pfizer
  • Ola Oyinloye, Associate Director, Medical Devices and Combination Products, AstraZeneca
  • Justin Metcalf, Associate Director, Global External QA Operations, Alkermes
  • Margaret Kelly, Device Manager - Processes, Novartis
  • Patrice Becker, Global Director Scientific Communications / Surgical Innovations Medical Affairs, Medtronic
  • Amanda Matthews, Sr. Director, Regulatory CMC for Combination Products & Medical Devices, Pfizer
  • Thomas Fischer, Head Quality Medical Device Development, Novartis
  • Milena Roux, Regulatory Professional, Novo Nordisk
  • Julia Frese, Department Manager Centre of Combination Products, TuV SuD
  • Chris Minnich, Device Project Director, Merck Group
  • Clemens Gunther, Director, Nonclinical Safety Customer Care, Bayer
  • Anja Nielsen, Principal Medical Device RA Professional, Leo Pharma
  • Arabe Ahmed, Medicinal Technical Expert, BSI

Meet Our Advisory Board Members

  • Susan Neadle, Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
  • Tina Amini, Head of Notified Body, Lloyd's Register
  • Khaudeja Bano, Head of Medical Affairs, Abbott Molecular
  • Clemens Gunther, Director, Nonclinical Safety Customer Care, Bayer
Pre-Conference Troubleshooting Clinic - 22nd October 2019

Main Conference Days
- 23rd - 24th October 2019

Venue

Mercure Hotel MOA Berlin
Stephanstrasse 41, 10559
Berlin, Germany


Website: https://www.accorhotels.com/gb/hotel-A0F7-mercure-hotel-moa-berlin/index.shtml
Phone: +49 30 3940430

Accommodation
Travel and accommodation are not included in the conference fee; however we have put together a HotelMap that displays discounted accommodation for hotels in the area near to Combination Products 2019. The map displays live availability and allows you to book directly with each hotel: https://www.HotelMap.com/pro/MGY4T

Please note: We will never recommend, approve or appoint any third party rooming service to act on our behalf. Please be extremely wary if you are approached by any such companies. We will always endeavour to negotiate the best available rates for you so please use the HotelMap link provided; this shows live availability and rates for all hotels in the area and allows you to book directly with the hotel of your choice within your budget.