Company: GIFLF
Filing Date: 2025-02-26
Form Type: 6-K
Source: 0001104659-25-017501
Chunk: 56

Company: Grifols SA
Filing Date: 2025-02-26
Form: 6-K
Chunk 56
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 Several measures at Grifols ensure the transparency of data collected in           
 its clinical trials while safeguarding the anonymity of trial subjects and         
 the protection of their personal data in accordance with the General Data          
 Protection Regulation (GDPR). Grifols also subscribes to the principles of         
 the codes of conduct regulating the treatment of personal data from clinical       
 trials and other applicable clinical and pharmacovigilance research.               
 Information on the protocol, status of clinical trials and their results are       
 disclosed on publicly accessible registries, including www.clinicaltrials.gov      
 In addition, the results of trials conducted in Europe are published in            
 the EudraCT (European Union Drug Regulating Authorities Clinical Trials            
 Database) when the trial is regulated by Directive 2001/20/EC, and the             
 Clinical Trials Information System (CTIS) platform when the trial is governed      
 by Regulation 536/2014.Grifols also publicly shares the results of many of         
 its clinical trials at international conferences and in scientific journals.       
 Responsible testing                                                                
 Grifols is committed to the responsible use of laboratory animals when             
 required for the development of new life-sustaining therapies.                     
 Whether studies are carried out in university settings or in external              
 laboratories, Grifols researchers work closely with regulatory agencies and        
 the Institutional Animal Care and Use Committee (IACUC) to guarantee the           
 safe and ethical treatment of animals.                                             
 All facilities are approved by the competent authorities where research            
 is conducted. In the U.S., Grifols facilities are certified by the Association     
 for Assessment and Accreditation of Laboratory Animal Care (AAALAC)                
 or equivalent organization, and hold the highest accreditation possible for        
 animal-testing laboratories.                                                       
 All European laboratories comply with Directive 2010/63/EU concerning              
 the protection of animals used for scientific purposes and are assessed            
 by the competent authorities of each country. Grifols research adheres to          
 the “Alternatives and the 3Rs” (Replacement, Reduction and Refinement)             
 protocol, which advocates (i) Replacing the use of animal-testing with             
 alternative techniques or avoiding it completely; (ii) Reducing the number of      
 animals used; and (iii) Refining how experiments are performed to ensure           
 animals suffer as little as possible.                                              
 More information: ClinicalTrials.gov and EudraCT                                   |

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