Ingrid Klingmann

Dr. med. Ingrid Klingmann is specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine.After having joined pharmaceutical industry as medical advisor, she held senior management positions in different international contract research organisations and was responsible for operational, scientific, regulatory and business aspects of international clinical research projects from Phase I to Phase IV.Since January 2003 she has her own pharmaceutical development and site management support consulting company. For 4 years she was also CEO of two investigative sites in London, UK, performing clinical trials in acute and chronic pain as well as musculo-skeletal diseases.Dr. Klingmann is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP). On behalf of EFGCP she was Work Package Leader of the PatientPartner Project and is currently Coordinator of the IMI project PharmaTrain and she is Work Package Leader of EUPATI, responsible for developing the EUPATI Network, the EUPATI National Platforms and the Ethics Panel. Dr. Klingmann chairs the clinical research module of the post-graduate Master in Regulatory Affairs course at the University of Bonn, Germany, and co-chairs the Diploma Course in Clinical Trial Practices at the University of Basel, Switzerland.

The European Forum for Good Clinical Practice (EFGCP) and MedTech Europe, have created a common Working Party aimed at addressing ethical and quality issues when setting clinical standards for the rapidly developing medical technology sector. Indeed, the upcoming regulation on medical devices and in-vitro diagnostics will change the landscape for their development in Europe. Many elements of these regulations have not yet been finalised by the parties involved. An agreement between the parties requires in-depth multi-stakeholder discussions to ensure that the new regulatory framework will facilitate the rapid clinical development of efficient and safe medical devices and in-vitro diagnostics. Historically, the clinical debate has focused on pharmaceuticals. It is important that we engage in a conversation about lessons learned. Systematic concepts might be applied to the medical technology sector as well and conditions that are different in the medical device/in-vitro diagnostic area may need researched solutions. That is why the EFGCP-MedTech partnership is involving a full range of stakeholders including patient representatives, academics, healthcare providers, ethicists, competent authorities, industry and policymakers in a dialogue to collect views and work out implementation suggestions on good clinical practices. Only with a vibrant dialogue can we figure out which direction is right for medical technology and above all for the patient. There is also a need for better control of the regulatory system to ensure that outcomes for patients are safe and effective. The interest in tailoring the technology to the needs of the patients, and ensuring quality and ethical principles as well as harmonized standards in clinical trial performance, are shared by both the medtech industry and EFGCP. For the patients, ethical standards should ensure the protection of research subjects’ life, health, dignity, integrity, right to self-determination, privacy and the confidentiality of personal information and active involvement by patients in the research...