#9 Practical RWE – Connecting the Dots: How to Identify Country-Specific Requirements for Non-Interventional Studies (NIS)
Psstt…this is a secret…so please don’t tell anybody! 😳 🤔 😂
How do we identify the country-specific requirements for non-interventional studies? Much of our work with non-interventional studies involves determining what is NOT applicable.
We start with clinical trials…and run through this series of questions:
- What are the Requirements for Clinical Trials?
- Are NIS Covered in the Clinical Trial Regulations?
- Are There Specific Regulations for NIS?
- Are There Specific Regulations for Biomedical Research?
- Is There Local Guidance for Biomedical Research?
The answers to these questions help us to build our country-specific regulatory compliance roadmaps. Part of the process includes contacting competent supervisory authorities (e.g., IEC/IRB) to confirm (verify) NIS requirements.
Simple!
Share this story...
Lithuania – Leaping into Digital Health Future with RWE and RWD Innovations
RWE 201 - Lithuania – Leaping into Digital Health Future with RWE and RWD Innovations EU Partnership Agreement: https://ec.europa.eu/commission/presscorner/detail/en/ip_22_2547Lithuania is actively implementing Real-World Evidence (RWE) and Real-World Data (RWD) [...]
RWE Guest Post – Does Real-World Evidence Play a Role in G-BA’s Benefit Assessments in Germany?
RWE 201 - RWE Guest Post - Does real-world evidence play a role in G-BA's benefit assessments in Germany? Guest: Anja PownellGerman Market Access – Simplified: https://germanmarketaccesssimplified.com/IntroductionThe German [...]
RWE Guest Post – Germany – From Concept to Evaluation: The Journey of RWE requests by the G-BA
RWE 201 - RWE Guest Post – Germany - From Concept to Evaluation: The Journey of RWE requests by the G-BA Guest: Anja PownellGerman Market Access – Simplified: [...]
Spain – Championing the Ethical and Responsible Use of Real World Data
RWE 201 - Spain – Championing the Ethical and Responsible Use of Real World Data Farmindustria Code of Conduct: https://codigoprotecciondatos.farmaindustria.org/sites/medicamentosinnovadores/docs/PRODF484450.pdfIn 2022, the Spanish Data Protection Agency (AEPD) gave its [...]
EU – RWD/RWE is Embedded into the New EU Medicines Regulations
RWE 201 - EU – RWD/RWE is Embedded into the New EU Medicines Regulations Coming Soon…New EU Medicines Regulations: https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_enIn 2023, the European Commission undertook an ambitious overhaul of [...]
EU – EU’s Action Plan for Real-World Data (RWD) & RWE
RWE 201 - EU – EU's Action Plan for Real-World Data (RWD) & RWE The European Union has embarked on an ambitious journey to weave Real World Evidence (RWE) [...]
