12. Resources (listed in descending order of precedence)
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12. Resources (listed in descending order of precedence)
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European Union
- EU Clinical Trial Regulation (EU CTR) 536/2014
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20220131
- EMA- Questions and Answers Document Regulation (EU) 536/2014
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-10_en
- EU Clinical Trial Register
https://www.clinicaltrialsregister.eu/ctr-search/search
- EMA- Clinical Trials Information System (CTIS): online training modules
- EMA CTIS Evaluation Timelines
- EMA Guideline on Computerised Systems and Electronic data in Clinical Trials
- EMA- Recommendation Paper on Decentralized elements in clinical trial
- EMA Serious Breaches Guidance_30 June 2023
- EMA- Appendix IIIb- Information to be submitted with a notification of a serious breach.
- European Commission- Customs clearance documents and procedures
https://trade.ec.europa.eu/access-to-markets/en/content/customs-clearance-documents-and-procedures
- EFPIA Code of Practice
https://www.efpia.eu/relationships-code/the-efpia-code/
- EMA- Paediatric Investigations Plan
- European Judicial Network- Parental Responsibility-child custody and contacts rights
https://e-justice.europa.eu/content_parental_responsibility-302-be-en.do?init=true
- EMA- European Network of Paediatric Research at the European Medicines Agency- Informed Consent for Paediatric Trials in Europe 2015 (revision 06 June 2023)
Belgium
- Federal Agency for Medicines and Health Products (“FAMHP”)
https://www.famhp.be/en/human_use/medicines/medicines/research_development/clinical_trials
- Clinical Trial College (CT College)
- Clinical Trial College (CT College)- List of recognized Ethics Committees
- Law on Clinical Trials of Medicinal Products for Human Use_07 May 2017
https://www.ejustice.just.fgov.be/cgi_loi/change_lg_2.pl?language=fr&nm=2017012146&la=F
- Royal Decree implementing the law of May 7, 2017 relating to clinical trials of medicinal products for human use
https://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&cn=2017100913&table_name=loi
- Royal Decree, 28 September 2009, Setting the Quality and Safety Standards for the Donation, Collection, Procurement, Control, Processing, Storage and Distribution of Human Body Material, to Which the Banks of Human Body Material, Intermediate Structures of Human Body Material and Production Establishments Must Meet
https://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&cn=2009092808&table_name=loi
- Law 07 May 2004- Law in Human Research
https://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&cn=2004050732&table_name=loi
- FAHMP- CTIS document requirements
- FAHMPS page related to authorization to manufacture, distribute, export, and hold medicines.
- FAHMPS- Online Clinical Trials Database
https://www.famhp.be/en/clinical_trials_database
- FAHMPS- National Innovation Office
https://www.famhp.be/en/innovationoffice
- Belgium- Guidance for Sponsors on the Use of Electronic Informed Consent in Interventional Clinical Trials in Belgium_V2.0_29 June 2022
- Belgian Act of 30 July 2018 on the protection of natural persons with regard to the processing of personal data.
https://www.dataprotectionauthority.be/publications/act-of-30-july-2018.pdf (Unofficial English translation)
- Law of 19 December 2008, relating to the Obtaining and Use Of Human Body Material Intended For Human Medical Applications Or For Scientific Research Purposes
http://www.ejustice.just.fgov.be/eli/loi/2008/12/19/2008018385/justel
- Royal Decree 28 Sept 2009, laying down the quality and safety standards for the donation, collection, procurement, control, processing, storage and distribution of human body material, to which human body material banks, human body material intermediate structures and production establishments must comply
https://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&cn=2009092808&table_name=loi
- Royal Decree of 09 Jan 2018 on Biobanks
https://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&cn=2018010914&table_name=loi
- AFMPS-Biobank Compedium
- Belgium- Act 22 August 2002- Act on the rights of the patient
https://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=fr&la=F&cn=2002082245&table_name=loi
- BECRO:
https://www.becro.be/about-becro/
- BAREC- Statement on Decentralized Trials
https://barec.be/statement-on-decentralized-trials/
Related to GMO:
- FAMHP- Belgium Regulatory Guidance on the use of genetically modified organism in a clinical trial
https://www.famhp.be/sites/default/files/Guideline_CTR_GMO_October_2023.pdf
- Belgium Biosafety Server
- Belgium Biosafety Server- Belgium Regulatory Framework on BioSafety
https://www.biosafety.be/content/belgian-regulatory-framework-biosafety
- European Commission- Genetically Modified Organism (GMO) aspects for investigational medicinal products
- European Commission- National procedures that must be followed for the conduct of clinical trials with medicinal products that contain or consist of GMOs.
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