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RAPS' Latest | 18 January 2023 | By Ryan Connors
Kim at RAPS Convergence 2022 in Phoenix, Arizona.
Since she first got involved with RAPS in the mid-1990s, Kim Young has been a mainstay among our organization’s rapidly growing European membership. In October 2022, Kim joined RAPS as its first full-time European employee.
As our Regional Engagement Director in Europe, Kim won’t just be on the ground at RAPS’ European events. She’ll also be around virtually to help chapters, local networking groups and members get the most out of their RAPS memberships — and to make sure RAPS is serving the needs of European regulatory professionals.
Kim joined us from her home office in Wales for a chat about her career in regulatory affairs, the path that led her to RAPS, what she hopes to accomplish and much more. This conversation has been lightly edited for clarity.
I've been involved with RAPS since about 1994 or 1995, because RAPS Convergence was my very first professional conference. I still remember the thrill of having the opportunity of networking with other regulatory affairs professionals, industry experts and health authority representatives. As a new professional, that first conference was a fantastic opportunity to learn. It was just so wonderful to see so many peers in one location.
My involvement has changed over the years as I've moved through my career. I've always been an on-and-off member to RAPS because of changes in my roles and changes in employers. But I can say that wherever I've worked, I've always pushed and championed the ways in which RAPS can play in creating, educating and sustaining regulatory teams to become more successful within organizations.
Over the past few years, I've become more involved with many varied regulatory affairs professional associations. I've created webcasts, I've spoken at conferences, chaired committees and I've mentored young professionals. My last volunteer role with RAPS was supporting the RAPS Euro Convergence committee, during which I met the fantastic team that I'm working with now.
Before I joined RAPS, I guess you could say I had a very unusual working career. I've worked in different industries: innovative pharmaceuticals, sterile generics, combination products, medical devices, OTC drugs, cosmetics, even for a software company creating platforms dedicated to support regulatory information databases. I was also fortunate enough to take a 10-year regulatory career break as a mum. Which roles have I really enjoyed? Well, I think I'm really lucky that I can honestly say that I've enjoyed all of my roles because each one was very different from the next.
And many of my roles were created just for me, so I didn't have to fill anybody else's shoes. So, this allowed me to create my own processes and systems, which meant that I could make mistakes to learn from and also bring new ideas to the table. Having such a diverse professional background has provided me with different, diverse examples from which I can employ for different possible solutions.
Firstly, I’d like to say that I am indeed honored to have become RAPS first European staff member. It was one of those times when I was having an aside conversation which then coalesced into a possible approach to opening the door for me to fill this role. And I have to tell you, as soon as I read the job description, I knew I was the right person to take on this new challenge.
My role is to support the RAPS’ global team in order to build insights to maximize our engagement with health industry regulatory affairs professionals that are based within Europe and beyond. So I facilitate the development and implementation of the strategies for RAPS involvement, including partnerships with the European regulatory agencies, other regulatory professional educational activities and additional outreach programs, and also our RAPS Chapter and Local Networking Group events. I'm also here to promote diversity and inclusion by encouraging global participation within the RAPS community.
Basically, just to wave the flag across Europe as someone available for queries and questions and to support our growing membership. Anyone who’s listening or reading this interview, please, please, please feel free to contact me.
You can find Kim on LinkedIn here and on RegEx here. Her email is email@example.com.
Something that all of us need to remember is that “European” regulatory affairs is not a completely single entity.
I mean, yes, we have the European Commission and the European Medicines Agency. However, each one of the 44 European countries maintains its own subset of laws and regulations and guidelines to which the pharmaceutical and medtech industries must adhere. And not to mention that there are 24 official languages to contend with for labeling and marketing translations.
And I have to say this as a special note that the United Kingdom is still in Europe. It's just not under the aegis of the European Union. So, yes, we are now treated as a third country, the same as the US or Australia. But then there's the Northern Ireland protocol. So, I'm just going to stop right there because, yes, it's complicated, and I'll leave that for a deeper discussion on that topic for another time.
In my opinion, one of the biggest challenges facing all regulatory professionals, Europe, North America, China, Brazil, everywhere, is this mandatory need for creating, analyzing, maintaining, submitting and archiving all of the disparate data to successfully obtain and maintain marketing approval.
Another challenge is the lack of a harmonized approach from the global health authorities to drug and device approvals. Because this lack of harmonization drives the increase in data management. And not only do we have to contend with an increase in data, the absence of harmonization, but also a shortage of concrete guidance and clarity of these on harmonized approaches to gaining marketing approvals.
So, there are a lot of those who believe the healthcare innovation will stagnate in Europe because of the increased regulatory burden. But of course, for all of us as key stakeholders, the primary goal is to assure that safe and effective health enhancing products are available to those who need them—the patients and the health care professionals.
RAPS provides a neutral platform for regulators, industry, healthcare professionals and importantly patient advocates to share their thoughts and opinions and build relationships to try to solve these challenges, which ultimately affect us all. We believe empowering regulatory professionals is key to breaking down some of the obstacles to success.
I can talk about this for a long time. I like eating and traveling (52 countries thus far!) I'm a bona fide foodie. I love to cook. I like to try new recipes and, of course, eat. At one point in my household, we had over 250 cookbooks. But now, with the availability of the Internet, we pared the library down to about 80. I love the cuisines of the world, so please don't ask me to choose a favorite.
You can find Kim on LinkedIn here and on RegEx here.