Real Regulatory to Attend the TOPRA Symposium 2019
Will you be at the annual TOPRA Symposium 2019 in Dublin?
The Annual TOPRA symposium brings together the pharmaceutical, medical device and veterinary communities for one of the key events in the European regulatory affairs calendar for anyone working as, or alongside, regulatory professionals.
Drop by booth #2, where our expert team of consultants will be on-hand to help you discover how Real Regulatory can support and advise your company on meeting regulatory obligations for medicines, medical devices, and drug device combinations.
Chat with our team about how we can produce bespoke strategies no matter the phase of development, adding value to the product, and ensuring timely approvals.
To arrange a meeting at a time convenient to you, contact us today. We look forward to seeing you there!
Karen was a co-founder of the company in 2002. Involved in the pharmaceutical industry since 1994, she has been employed in compliance and regulatory positions within both the generics and ethical medicines industries, and in a Contract Research Organisation.
Now in her 19th Year of running the regulatory function in Real Regulatory, Karen has extensive experience in all aspects of the life of a medicine, from development strategy, CTs, and gaining approvals and lifecycle management for MAAs in Europe. As a Director, she is also responsible for team management, business development and the service realization process. Over the years Karen has built an expansive network within the global pharmaceutical industry.
Dorothée joined the company in May 2006 and has worked in regulatory affairs since 2003 mainly in human medicinal product, including small chemical entity and biotechnology products. Previously Dorothée was part of the CMC regulatory team at the manufacturing site of a major pharmaceutical company.
Dorothée’s current role is as Managing Consultant of the Irish office.
As part of the management team Dorothee has managed projects through the full product lifecycle from early development to product maintenance and MAH compliance. She has also supported several clients in preparation of inspection readiness. Dorothée oversees and manages our Irish office whilst providing expert consultancy to her client projects.
Leslie joined the company in April 2017 and has worked in EU regulatory affairs since 1997 mainly in human medicinal products, including advanced therapies and clinical regulatory support, both within small/medium pharma and as consultant/CRO with small to large pharma clients.
Leslie’s current role is as Managing Consultant in charge of the UK office, managing a growing team of consultants whilst providing expert consultancy to client projects.
Leslie is a current holder of the Regulatory Affairs Certification [RAC(EU)] credential and a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA). She has experience in a variety of therapeutic areas including gene therapy, oncology, neurology and respiratory.