Comments on guidelines
Good Lay Summary Practice - AGAH comments to draft document
Comments on a draft guideline of the Roadmap Initiative on Good Lay Summary Practice
With the start of the practical implementation of the new EU Clinical Trial Regulation (probably in spring 2022), summaries of study results for all early phase clinical trials must also be prepared in a way that can be understood by laypersons.
Within 12 months after the end of the study (30 months for non-therapeutic studies), the lay summaries must be made available to the public via the central EU portal. This is uncharted territory for many parties involved - from clinical study centers to CROs and the pharmaceutical industry - and we must prepare ourselves accordingly. For this reason, a Roadmap Initiative has been formed in 2019 under the leadership of EFGCP and EFPIA. More than 50 organizations are participating in this initiative to create a practical Guidance Document on Good Lay Summary Practice.
The AGAH has commented on this draft guideline and submitted the statement
Lay_summary_guidance_comments_AGAH
https://efgcp.eu/documents/GoodLaySummaryPractice_PublicConsultation199.pdf
September 2020
Comments on Data Monitoring Committees issues
Submission of comments on 'Questions and answers on Data Monitoring Committees issues’
(EMA/492010/2018) (2019)
Transparency of the “Functional specifications for the EU portal and EU database to be audited"
Submission of comments on 'Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited"'
(EMA/42176/2014) (2015)
Dermal Response Score System
Statement of Arbeitsgemeinschaft Angewandte Humanpharmakologie (AGAH):
Dermal Response Score EMA/CPMP/EWP/280/96 Corr1, Appendix I (2015)
Strategies to identify and mitigate risks for first-in-human and early clinical trials
Submission of comments on 'Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products'
(EMA/CHMP/SWP/28367/07 Rev. 1) (2017)
Risk proportionate approaches in clinical trials
Comment to consultation document: risk proportionate approaches in clinical trials (2016)
Entwurf eines Vierten Gesetzes zur Änderung arzneimittelrechtlicher und anderer Vorschriften
Stellungnahme der Arbeitsgemeinschaft Angewandte Humanpharmakologie (AGAH e.V.) zum Referentenentwurf des Bundesministeriums für Gesundheit:
Entwurf eines Vierten Gesetzes zur Änderung arzneimittelrechtlicher und anderer Vorschriften (2016)
Strahlenschutzgesetz
Stellungnahme der Arbeitsgemeinschaft Angewandte Humanpharmakologie (AGAH e.V.) zum Referentenentwurf des Bundesministeriums für Umwelt, Naturschutz, Bau und Reaktorsicherheit, RSII1:
Strahlenschutzgesetz (2016)
Stellungnahme der AGAH zum Referentenentwurf Strahlenschutzgesetz
Modernisierung des Strahlenschutzrechts
Gemeinsame Stellungnahme zum Referentenentwurf des Bundesministeriums für Umwelt, Naturschutz und nukleare Sicherheit:
Verordnung zur weiteren Modernisierung des Strahlenschutzrechts (2018)