Top 10 Possible Effects of Brexit on Clinical Research

So, now that the people of the U.K have voted to leave the European Union, I wanted to know how this is going to affect Clinical Research and the Pharmaceutical Industry.  I've been reading a few things, talking to a few of my colleagues and here is Pharma Mama's summary, (in no particular order), a quick reference guide and a few questions post vote:

1. The European Medicines Agency (EMA) headquarters will  be moving from London, (the move of about 600 jobs).
2. Will the Medicines and Healthcare products Regulatory Agency, (MHRA), continue to conduct inspections with the EMA?  
3. Are the UK now going to have their own drug approval system as these have typically been determined at the EU level?
4. Will the EMA now lose the ease of accessibility to MHRA experts? The Financial Times highlighted that MHRA experts led the review of more drug applications that any other domestic EU regulatory in 2014.  That's a lot of expertise!
5. Even though the UK will be departing, there will be laws that will remain in place because there were EU Directives that required them to implement relevant legislation into national law, (unless the government decide otherwise). 
6. We have been used to seeing the MHRA and EMA working side-by-side inspecting manufacturing facilities.  Are we now going to see the MHRA functioning more like the Swissmedic, (Switzerland's regulator), independently authorizing medical products but working with the EMA under mutual recognition and shared agreements?  Or are we going to see an addition to the list of countries outside working with the EMA?  (Norway, Iceland and Liechtenstein function in this way).   
7. Most major players in the world of big pharma seem to have expressed that they would have preferred for the vote to be remain.
8. It is argued that the UK is currently involved in about 40% adult rare disease trials.  Now that the vote to leave has been cast, could this be now undermined? 
9. As the UK will no longer be part of harmonized procedures in the conduct of clinical trials, are they going to lose out on trials that could be beneficial to patients?
10. It could take years before the full impact of the decision for the UK to leave the EU is felt on the pharmaceutical industry.

What the industry experts are saying:

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry  - the decision "creates immediate challenges for future investment research and jobs in our industry in the UK".

Steve Bates, chief executive of the BioIndustry Association (BIA) - "several key issues for our sector are now in flux.......Key questions about the regulation of medicine, access to the single market and talent, intellectual property and the precise nature of the future relationship of the UK with Europe are now upon us".

Sarah Hanson, Head of UK Lifesciences, CMS Cameron McKenna LLP - "First and foremost we must consider its effect on the significant body of EU legislation which governs the development and supply of medicines and medical devices........Companies engaging in any way with the EEA markets will face increased regulatory burdens from having to deal with separate UK and EU regulations so the industry faces an arduous job ahead, keeping abreast of all relevant legislation to work out which parts of the UK and EU regulatory regimes will remain the same and which parts will diverge" 

And They are Out.......BREXITED....GONE, My First Personal Thoughts....

I just got a nice surprise, my husband came home early, so had the crazy idea to run here quickly to sit down with you for an impromptu chat, but now my 1 year old, (who I just had to intercept from drinking toilet water for the umpteenth time),  is having a super-human strength moment, spinning me around on my chair........I will prevail...

So, I had planned on my next post being about how I got into the pharmaceutical industry, but #BREXIT derailed me slightly......so we'll come back to that another day.

One of the greatest, most unanticipated side effects of having a career in the pharmaceutical industry for me, has been the opportunity I've been afforded to meet, work closely, collaboratively and successfully with so many fascinating people from around the world.  I started my career as a Clinical Research Associate, (CRA), in the UK, travelling Europe.  I then moved to the U.S continuing my CRA career, (more details to come in my 'how I got into the industry' post).  My education about the world and its people has been first class because I have been lucky enough to experience and indulge in different cultures first hand.    

Something that has always, (and continues), to fascinate me during my career in clinical research has been the amazing skill and ability of teams that I work with to all understand, speak, read and write English!  Perfectly!!!!

You see, clinical research, (like many other industries I'm sure), is completely global and luckily for me, (because sadly I'm only fluent in 2 languages,UK English and American English), English is the primary language used by international teams.

A single team can consist of members from every continent across multiple time zones.  Rarely is English the first language of the majority of these fascinating people, (and actually English often ranks 3rd, 4th on their list of languages spoken).  I've often heard from my colleagues, ' I'm so sorry, my English isn't so good' and all I'm thinking is, 'I can't even start to make an apology in anything other than English!'

Through work, I have made life long friends, from around the world, (one of the many perks: great savings on hotels come vacation time :).  Yes, we've worked together, but more importantly for me, I've got to learn, understand and appreciate more than any geography class could every teach me.  I can't think of a downside of getting to know and being able to interact freely with any of my international colleagues.  Yes, social media, the internet etc., make the world smaller, but nothing beats shaking the hand of that person you've been tirelessly working with for months, sometimes years, who up until that moment you could only recognize by voice through a polycom.

Like everybody else I'm waiting to see what's going to happen now that the vote to leave prevailed.  The pharmaceutical industry is going to be hit and maybe clinical research in the UK is going to look very different.  However, what I do know definitively is that I'm going to hold on even tighter to my personal global community, with the intention of continued expansion, because it works for me.

I've Joined Twitter...........come follow, follow, follow, follow, follow, follow Me! (Do you know that song??? Sorry if you don't)

Hey There!

I hope you are well.  Just a quick note to let you know that I've just joined Twitter.  I can Tweet now :) My handle @pharma_mama is waiting to be followed by you.  Now you can hear what's going on in my world in real time......

Look our for my next blog when I let you know when, why and how I got into the Pharmaceutical Industry.

Until then........

Welcome!! So What's This All About....................

Hi There!  Thanks for stopping by!  Welcome to my blog.  My name is Lisa Collins.  I am a wife, mother to 3 phenomenal children, (currently 6, 5 and 1.......yes I am busy, yes my hands are full....you don't know how I do it?  Well I don't really have an option when the primary endpoint is their survival, yes I do get tired, yes, yes, and yes..........), and I am a Pharmaceutical Industry Professional.

I have worked in the pharmaceutical industry for 16 years, and if there is one thing that I have realized, it's that most people don't know what I do, (including those closest to me, like my mom and my best friend, lol).  I am often asked, What is it that you do?  What is clinical research?  How do I get into the industry? What job opportunities exist? How do those drugs get onto the market?  What are all of those companies up to?  What is a Biotech?..........I could go on and on, but I think you get the point.  The Pharmaceutical Industry is a bit of an enigma to those on the outside, and even parts of it are a mystery to those of us on the inside.

So here is my opportunity to answer the many questions that I am asked on a regular basis, and to satisfy some of my own curiosities.  I'll give you my advice, my opinions, I'll chat to people across the industry, I'll chat to my industry friends!  I'll keep an eye on the latest industry happenings. I'll bring you all of this and more from my perspective, a pharmaceutical professional, raising a family while on my journey to living a purposeful life.

If there is anything that you would like to know about the Pharmaceutical Industry, (or juggling 3 mini people with the demands of making new drugs), feel free to drop me a line and I will respond as best as I am able.

So here we go, journey into my world of drugs, minis and everything me!  

See you later!