Ensuring that combination products are effectively managed throughout their development, implementation, launch and post-market surveillance is critical to their long-term success in the market.
However, the interaction between medical device manufacturers and pharma companies arguably still has considerable room for improvement and both face various challenges throughout the product lifecycle. In order to facilitate an efficient development process and launch combination products successfully, the two partners must be fully aligned throughout the product lifecycle.
Ahead of the Combination Products Forum, Pharma IQ surveyed the industry experts to understand what are the biggest challenges faced by them at each stage of the lifecycle management as well as what’s stopping them from implementing new solutions.
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We were pleased to welcome John Weiner, Associate Director, FDA Office of Combination Products, FDA, at last year's Combination Product Forum. He discussed the FDA Regulatory Landscape, where he discussed the regulation of other combined uses of medical products in the US.
Key highlights which were addressed throughout the presentation:
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Johnson & Johnson’s Senior Director of Global Value Chain Quality Design, Susan Neadle shares her insights on how to effectively streamline your end-to-end combination product lifecycle management process.
Her presentation will give you insights into:
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In this exclusive interview conducted ahead of this year’s Drug-Device Combination Products conference, Jane Wilson, Product Safety Manager at Owen Mumford shares her top tips for how to successfully manage the entire product lifecycle, from planning and design to process and manufacture.
Download the interview for free to get Jane Wilson’s answers to the following questions:
Split across three days, the event will focus on one key question: Can you successfully launch and manage a combination product? With this in mind, our expert speaker panel will take you on a journey through a 100% interactive programme, helping you to:
Jane Wilson will also participate in a round table discussion at this year’s conference to identify the key strategies required to optimise lifecycle management processes, from concept to market. More information on the session can be found here.
Below is a preview of the interview:
Pharma IQ: What are the biggest challenges you experience when collaborating between medical device and pharma companies?
Jane Wilson: Developing a product whilst keeping the full product lifecycle in mind can be a challenge. There is just so much to focus on. The two teams are busy working to deliver the product to specifications and deadlines. We find with big pharma in particular that the teams who work on the development of a product often…
Amanda Matthews, Senior Director, Regulatory CMC for Combination Products & Medical Devices at Pfizer, provides an exclusive insight into the challenges of working between medical device and pharmaceutical companies, following the transition from development to commercial.
this year’s Drug-Device Combination Products conference, Amanda Matthews answers
the following questions:
Amanda Matthews will also participate in a round table and panel discussion at this year’s conference to discuss the impact of the EU MDR and how you can improve the collaboration to optimize processes. More information on the session can be found here.
Ensuring that combination products are effectively managed throughout their development, implementation, launch and post-launch is critical to long term success in the market. However, there is arguably still considerable room for improvement throughout this process, and in order to facilitate efficiency all parties must be fully aligned throughout the product lifecycle.
In order to explore this topic in more detail, Pharma IQ spoke exclusively to Dr. Tina Rees, Associate Director-Human Factors, Ferring International Pharmascience Center to discuss product lifecycle management and the areas where simple process improvements could make a significant difference to the overall success of a combination product.
Until now, combination products are more often handled inconsistently in different jurisdictions as drugs and/or devices. The determination as to which regulations, submission procedure and pathway to market is followed for the product is largely based on the its Primary Mode of Action, a new concept in itself.
Ahead of the Combination Products Forum 2018, we spoke exclusively to Viky Verna, Co-Founder and Vice President at confinis, in order to discuss the biggest challenges relating to the combination product regulatory landscape, the best compliance management approaches, and the industry’s outlook and direction towards regulation harmonisation.