Navigating the regulatory landscape, aligning drug-device departments and lifecycle management
Combination Products Forum 2018 will focus on the entire product lifecycle management process from planning, design, implementation, safety & risk assessment right the way through to post market maintenance.
Patients are taking an active interest in their personal health and demanding easy-to-use, integrated delivery and administration systems that are safe to use.
Through a range of workshops, panel discussions, roundtables and case study presentations, key topics will focus on navigating the regulatory landscape, change management & departmental alignment, device development, project management, product usability, human factors, integrating digital platforms and general management across the total product life cycle becoming critical.
Split across three days, the event will focus on one key question: How can you successfully launch and manage a Combination Product!
Attending this event will enable you to:
- 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
Speakers
- Susan Neadle, Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
- Lori-Ann Woodard, Associate Director Quality Compliance Combination Products, Teva Pharmaceuticals
- Udo Stauder, Global Device Project Leader, Sanofi
- Margaret Kelly, Device Development Project Leader, Novartis
- Dr Clemens Gunther, Director Nonclinical Safety Consumer Care, Bayer Healthcare Pharmaceuticals
- Steve Dew, Associate Director Combination Products and Medical Devices, Biogen
- Florian Tolkmitt, Regulatory Affairs and Clinical Evaluation Expert, Independent Consultant
- Bente Post-Pedersen, Program Lead, Biogen
- Tina Amini, Senior Technical Specialist, Lloyds Register
- Ettore Marzocchi, Devices Manager I, Device Technology, Novartis
- Heidi Horsch, Head of Corporate Strategy, Confinis
- Johannes Keuschnigg, Senior Manager, Regulatory & Medical Device, Sandoz
- Jonathan Kearns, Manager, Device Engineering, Pfizer
- Manuela Jaeschke, CMC Product Collaboration Director, Abbvie
- Viky Verna, Co-Founder and Vice President, Confinis
- Khaudeja Bano, Head of Medical Affairs, Abbott Molecular
- Tina Rees, Associate Director - Human Factors, Ferring Pharmaceuticals
- Paul Liston, Research Fellow, Trinity College Dublin
- Samuel Cromie, Assistant Professor, Trinity College Dublin
Please fill in your name and email to receive the conference agenda of this event.
Pre-Conference Workshops - Monday 29th October 2018
Confererence Day One - Tuesday 30th October 2018
Confererence Day Two - Wednesday 31st October 2018
Venue
Mercure Hotel Amsterdam City
Joan Muyskenweg 10, 1096 CJ
Amsterdam, The Netherlands
Venue
Mercure Hotel Amsterdam CityJoan Muyskenweg 10 Amsterdam 096 CJ
Netherlands
Website:
http://www.mercure.com/gb/hotel-1244-mercure-hotel-amsterdam-city/index.shtmlPhone: +(31) 20 7219176
AccommodationTravel 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 Forum 2018. The map displays live availability and allows you to book directly with each hotel:
https://www.HotelMap.com/pro/MA4AS 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.
