MDTServices
Medicines Development
& Training Services
About us
MDT Services is a network of independent high level experts for regulatory and HTA science, providing training courses and scientific advice on key stages of drug development and on data generation for marketing authorization and reimbursement purposes in Europe.
MDT Services provide both general regulatory and HTA support as well as specific training sessions and support relative to data requirements for a specific disease area or a specificity of a product in development (e.g advanced therapies)
Services
We provide training sessions as well as specific support in the following fields:
- Regulatory science (non-clinical and clinical development)
- Methodology of clinical trials
- Benefit Risk assessment
- PICO
- Relative efficacy and relative effectiveness assessment and how to fill the gap
- Health technology assessment in general (all health technologies)
- Outcomes assessment
- Patient-Relevant and Patient-Reported Outcomes
- Early access to market
- Scientific advice (regulatory, HTA)
- Risk-Based Approach in product development
- EU regulation on HTA
Aim
By professional and high level expert engagement, we aim at contributing to the excellence of private and public research related to the development of medicinal products and other health technologies with regards to the regulatory and HTA evidence generation in Europe.
We provide help on how to bridge efficacy - effectiveness gap in product development and how to resolve difficulties related to differences in data required by different HTA bodies.
Clients
Public and private institutions involved in drug research and development (pharmaceutical companies, consulting companies, institutional clinical research affiliates, patient organisations) needing training in regulatory science and health technology assessment, methodology of clinical trials, benefit/risk and relative effectiveness assessment for reimbursement purposes, and risk-based approach in products development.
When necessary, MDT Services invites experts from different European countries familiar both with national and EU requirements in order to provide adequate joint support on HTA areas such as relative effectiveness ans cost effectiveness assessment, as well as country-specific requirements such as added benefit assessment of orphan and non-orphan drugs in Germany (see Services)