Did you know? About 4,000 clinical research employees in Germany have a valuable voice in the life sciences industry thanks to The Federal Association of Contract Research Organisations, (Bundesverband Medizinischer Auftragsinstitute, BVMA e.V.). Founded in July 1991, BVMA represents contract research organizations (CROs) based in German-speaking countries.
BMVA recently appointed OmniComm’s Yvonne Rollinger, Ph.D., to its Executive Board. Dr. Rollinger has been managing director of OmniComm Europe GmbH, the European headquarters of OmniComm Systems, for the past 10 years. She recently spoke with our social media team about BVMA. Here’s an excerpt from that conversation.
Who are the members of the BMVA?
Currently, there are 43 member companies, representing 4,000 clinical research employees. The members are service providers in research and development of pharmaceuticals and medical devices. As an EDC (electronic data capture) vendor with supporting services, OmniComm has a bit of an exceptional position in the Association.
What is your role as a member of the Executive Board?
First of all, I would like to express my sincere gratitude and acknowledgement to the prior Executive Board, especially to Dr. Dagmar Chase, who has been president of the Association since 2001. The previous Executive Board has positioned BVMA as an important stakeholder in our industry.
In past years, the Association has successfully sought representation on relevant regulatory bodies and industry institutions. As a co-founder and member of the European umbrella organization EUCROF (European CRO Federation), the BVMA is committed to further developing cooperation with EUCROF members, thus ensuring BVMA’s international representation and promoting clinical research of the highest quality in Europe and beyond.
The new Executive Board – Martin Krauss from FGK Clinical Research GmbH as president, Ralf Freese from CTC North GmbH & Co. KG as vice president, and me as Board Member – will build on that inheritance.
What are some of the goals?
We will continue to focus on keeping Germany attractive for clinical research and strengthening clinical research for the patient’s benefit. The Executive Board will facilitate the mutual exchange between the members. We are committed to representing the interests of German-speaking CROs at national and international meetings of regulatory bodies and institutions, and distributing information gathered during these meetings to BVMA members.
BVMA organizes regular seminars about hot topics. Recent sessions have included: Implementation of the EU Clinical Trials Regulation, eTMF, RBM and Data Privacy in Clinical Research. The next seminar – planned for the first half of 2018 – will target project management, with an emphasis on time management and communication. These seminars about industry relevant topics are free for employees of member companies. I enjoy this kind of extra training and exchange of thoughts, and I always try to attend all seminars, since they are so relevant.
How long have you been involved with BVMA?
OmniComm Europe GmbH became a member of BVMA in 2012. For several years, I have led the BVMA Risk-Based Monitoring (RBM) Working Group. We issued two surveys about the experience of European CRAs (clinical research associates) with RBM, and we published the results in the journal Applied Clinical Trials in 2016 and 2017.
I also really enjoy the informal contact and information exchange with the members, and the networking at the general assemblies and events.
What is the membership process?
The Association self-imposes a high quality standard among its members. Each applicant has to pass an audit, and all members undergo re-audits every three years. The audits are carried out by external auditors, and besides auditing the companies’ quality management systems as a whole, each re-audit focuses on a specific topic.
For example, in 2018 the audits will have an emphasis on ICH-GCP E6 (R2) compliance. This qualification process provides member companies with additional arguments for a positive positioning in the marketplace and clearly sets them apart from their competitors.
Why are industry associations so important to the life sciences industry?
The life sciences industry is very diverse, and it is undergoing constant changes. Digitalization is just one current example. It is, therefore, indispensable to have a body that facilitates close cooperation and exchange of information among its members. It’s also important to represent common goals and objectives in front of regulatory bodies, ethics committees and other stakeholders.
Other important objectives include constant education and knowledge transfer to the member companies’ employees to keep them up-to-date on the latest developments and trends related to the conduct of clinical research.
In addition to the free seminars, BVMA organizes an annual symposium, which takes place in November and has developed into a reputable conference in the industry with more than 300 participants. The symposium has become an established platform for the exchange of information in the community. It is also formally recognized as an educational resource for health professionals.
What about you?
I studied biology with a focus on microbiology and biochemistry in Bonn, Germany. I began my career in the pharmaceutical industry more than 25 years ago as a sales representative. Since then, I have held different positions: CRA, project manager and head of Clinical Services, as well as head of Compliance, and consultant for EDC and Change Management with various international pharmaceutical companies, CROs and EDC vendors.