August 29, 2022
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
I am the lead for European Regulatory Development, with a team of over 40 highly skilled nonclinical, clinical, CMC and regulatory consultants who support our clients navigate the regulatory maze within Europe. My role is to ensure that we exceed the unique needs of each client by building exceptional project teams, who use science to further our client’s objectives. Collectively, we dive deep into our client’s data to develop tailored strategies to ensure successful negotiation of the rigid and often inflexible regulatory landscape in Europe. We work closely with the client to execute agreed strategy and drive landmark approvals for innovative products.
To promote our incredible team and the invaluable services we provide. ProPharma Group offers specialized support to our clients across the entire product development spectrum – whether they are contemplating their nonclinical development plan to support first-in-human clinical investigation, or whether they are targeting an imminent marketing authorisation application and need our help to get it across the line. We can ensure that any company is best positioned to successfully achieve their goals, both business and regulatory and I want to ensure that the breadth of our capabilities is broadcast so that we can support more clients in reaching their next milestone and ultimately to deliver pioneering treatments to patients in need.
Early interactions with Health Technology Assessors should be a primary consideration for any company that is developing a product in Europe. Often the data package to support marketing authorisation for a product falls short of satisfying the clinical and economic considerations of the HTA bodies. Early engagement with the HTA authorities, whether through joint consultation with the EMA or not, can support the generation of a robust dossier that will consider both regulatory and HTA requisites to facilitate positive reimbursement outcome and help leverage the product to a wider patient population.
Where there’s a will there is a way – there is rarely a challenge that cannot be overcome by thinking laterally. Regulatory Science is an integral part of drug development, and regardless of the prevailing guidance or regulatory precedent, a focus on the science and data is what is needed to address regulatory expectations and get new medicines to patients with unmet medical needs. The global ProPharma Group regulatory sciences team are driven to do just that – utilise our profound scientific expertise in conjunction with our unrivalled regulatory proficiency to offer clients first-rate guidance and support to drive successful outcomes for their products.
I am the dutiful mother to a 2-year-old boy, who takes up most of my free time. Since having him, my priorities have changed somewhat – however thanks to an on-site creche I am able to frequent the local health club for a quick work-out. During the COVID lockdowns I did take up jogging to raise money for UK cancer charities – I intend to continue this but need to get some more training in first!
Although we are a large, global company, we have very much maintained a small company culture and are not stifled by layers of internal processes and constraints. We are adaptable to our clients’ needs and can offer clients valuable flexibility and agility while maintaining the utmost quality in all that we do. Just the other day we were able to collectively support a client who required our immediate support to meet a submission deadline in the EU, when another vendor had let them down. Although this request was received after EU working hours, our global team worked diligently with the client to ensure that the submission was completed within the deadline and to avoid delay to their ongoing procedure. Our dedication and determination to be the solution for the client is something that I value highly, and I am extremely proud to work at ProPharma Group amongst a wealth of like-minded people.
TAGS: Meet the Expert
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