The Clinical Forum programme features two full days of workshops and sessions with four core themes:
Theme 1 | Clinical Operations
Estrella Garcia, Head of Global Clinical Operations, Almirall S.A., Spain
Holger Maria Rohde, Director, Strategy Implementation Lead, Strategy and Business Operations Global R&D, Merck Serono, Germany
Health Authorities, the industry and clinical operations professionals are subject to continuous change: The new EU Clinical Trial Legislation is appearing on the operational horizon, risk based monitoring activities will be showing first results, pre-competitive industrial associations such as Transcelerate are gearing up, and more.
Theme 2 | Technical Operations
It’s time for the entire professional landscape to meet in Paris in 2015 to discuss the operational exploitation of these new concepts. The integration of these challenges into the existing clinical operations landscape is key to success, especially in order to deliver in times of demanding cost constraints. New management principles such as “lean management” and Six Sigma have been adapted for the R&D environment and are going to affect the way we work, trying to be more focused on patients and deliver even better quality in clinical research in record timelines.
Detlef Nehrdich, Senior Associate, Waife & Associates, Inc., Germany
Mette Mackeprang Bruhn, Team Leader, Data Management Standards & Support, Novo Nordisk A/S, Denmark
The Technical Operations Theme will focus on operational challenges caused by technical needs like eClinical integrations, business decisions like outsourcing or a mixture of different aspects like risk based monitoring. Managing the change, as well as prioritising the optimisation potential enabled by technology is a hot topic for many industry leaders and we will be presenting case studies on the Data Transparency initiative, the latest trends related to E-Source data, wearable technology and examples of risk-based approaches for system validations.
Theme 3 | Peri-Approval Research
Jens Reinhold, Medical Director ZAO Bayer, Bayer Healthcare Pharmaceuticals Russia, Russian Federation
Heike Schön, Managing Director, LUMIS International, Germany
Peri-Approval Research as the science that combines results and conclusions from clinical research activities with evidence based real life studies, will focus on the transition from clinical development to the product marketing phase and their integrated topics. These range from patient centred studies, data privacy and ethical challenges as well as early stage planning of real life evidence. With the public data accessibility and data sharing for observational studies we need a discussion around the type of governance and common standards which are needed for the industry, agencies and the public. The topics for the theme will provide the audience and the presenters an opportunity to discuss new challenges in peri-approval research as well as sharing recent experiences related to the regulatory guidances and recommendations shaping peri-approval research.
Theme 4 | Medical writing
Mary Gardner Stewart, Vice President, Medical Documentation, H. Lundbeck A/S, Denmark
Thomas Martin Schindler, Head Medical Writing, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Areas of interest include:
- Clinical operations, clinical research
- Clinical safety, pharmacovigilance and risk management
- eClinical / clinical data management
- Medical affairs
- Observational/non-interventional studies
- Medical writing
- Quality assurance
- Project management
- Business and IT computer system validation
- Patient advocacy
Pre-conference Tutorials are being developed for Monday, 13 April 09:00 – 12:30.
Watch this web space for programme highlights and more details!