If you are looking for ema policy 70 portal, simply check out our links below :
1. Clinical data publication | European Medicines Agency
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication
This is based on EMA’s flagship policy on the publication of clinical data. … Clinical data publication (Policy 0070) report Oct 2016-Oct 2017 … Publication channel, EMA clinical data publication website, Future EU portal and database.
2. Home – Clinical Data Publication – clinicaldata.ema.europa.eu …
https://clinicaldata.ema.europa.eu/
This website contains clinical data published under the European Medicines Agency (EMA) policy on the publication of clinical data. The clinical data have been …
3. Policy – Publication and access to clinical data (2019 revision)
https://www.ema.europa.eu/en/documents/other/european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use_en.pdf
portal
4. External Guidance on the implementation of Policy 0070
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data_en-1.pdf
portal
5. How to Navigate “EMA Policy 70: Publication of Clinical Data …
How to Navigate “EMA Policy 70: Publication of Clinical Data” and Ensure Compliance
Patient narratives: Policy 70 states that narratives are to be included in the redaction package and anonymized, rather than removed from clinical …
6. Optimal Strategies for Compliance with EMA Policy 0070 on …
https://www.appliedclinicaltrialsonline.com/view/optimal-strategies-compliance-ema-policy-0070-external-publication-clinical-data
Early attempts by companies to fulfil EMA Policy 0070 requirements have … content for the designated EMA portal, where anyone can look at it.
7. EMA Revises Guidance on Publication of Clinical Trials Policy …
https://www.raps.org/news-and-articles/news-articles/2018/11/ema-revises-guidance-on-publication-of-clinical-tr
The European Medicines Agency on Friday offered a look at the major and … The policy, known as “Policy 0070,” was adopted by the EMA …
8. Evaluating the re-identification risk of a clinical study report …
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-4120-y
Regulatory agencies, such as the European Medicines Agency and … of the manufacturers that has published dossiers on the EMA portal using a … The CSR was anonymized following the EMA Policy 0070 guidelines [12], …
9. Approach to EMA Policy 0070 – From Data … – LexJansen
https://www.lexjansen.com/phuse/2017/pp/PP18.pdf
According to the EMA Policy 0070 guidance [1] document: … at least two anonymization packages have been accepted, as per the EMA Clinical Data Portal [6],.
10. EMA Policy 0070: 5 ways to balance patient privacy with better …
https://www.pharma-iq.com/regulatorylegal/articles/ema-policy-5-tips
EMA Policy 0070 provides important guidelines and processes attached to the European Medicines Agency’s moves towards creating a public …
11. Latest Developments in the Transparency Activities of the …
Latest Developments in the Transparency Activities of the European Medicines Agency
As part of this plan, the Agency temporarily suspended Policy 0070. Currently, any clinical data submitted to the EMA by pharmaceutical …
12. The Evolution of Policy 0070: EMA Clinical Data Publication
https://www.diaglobal.org/productfiles/6605336/17119_PGM.pdf
Impact of the EU Clinical Trial Regulation and EMA Policy 0070 on … Technical Anonymisation Group (TAG)} and the status of the Portal used.