Datacreds’ Post

📚Are your investigative sites following the Global C-SSRS Training Standards for your clinical trial? 📚 TRANSNATIONAL STANDARIZED TRAINING VERIFICATIONS AND DOCUMENTATION FOR REGULATORY AUDITS, PATIENT, SUBJECT AND PUBLIC SAFETY AND GDPR/PRIVACY READINESS. To Learn More Contact: Corriepalm@bluecloud.net #Compliance #Standards #Regulatory #SubjectSafety

The March 2024 FREE PharMarketing GDPR Life Sciences Data Protection, Data Privacy #Newsletter has been issued!  Subscribe Now: write to: contact (at) pharmarketing.net Read the article from our Senior Consultant Ersi Michailidou about #Data #Altruism and Data #Sharing under the new EU Regulatory Landscape of the Data Governance Act #DGA and the European Health Data Space #EHDS, and the interplay with #GDPR and Guidelines from #ClinicalResearch! #dataprotection #GDPR #privacy #lifesciences #regulatoryaffairs #compliance #GDPR #HIPAA #HEALTHCARE #HEALTHDATA #privacy #dataprotection #lifesciences #medicalresearch #clinicaltrials #healthdata #patientdata #GoodLaboratoryPractices #ich #gxp #ISO27001 #CTR #MDR #drugs #pharmaceuticals #medicaldevices #IVD #MDR #EDPB #EDPS #adequacy #authorities #EMA #FDA #ICF #EHDS #HEOR #RWD #RWE

EMA has released an updated version of the Data Protection Notice for EudraVigilance, reflecting significant legal and operational enhancements to ensure compliance with evolving regulations in pharmacovigilance. Key updates include: -Enhanced security protocols and multi-factor authentication to safeguard sensitive data. -Revised procedures for processing Individual Case Safety Reports (ICSRs) to improve data quality and streamline reporting. -Privacy measures updated in alignment with GDPR and EUDPR, ensuring transparency and protection of personal data. Legal basis for processing personal data for PV purposes: -Legal obligations of joint controllers are justified under Article 5(1)(b) of the EUDPR and Article 6(1)(c) of the GDPR. -The lawful processing of special categories of data within these obligations is grounded in Article 10(2)(i) of the EUDPR and Article 9(2)(i) of the GDPR. Read the full document here: EMA Data Protection Notice: https://lnkd.in/dWWjcpJW #Pharmacovigilance #EudraVigilance #DataProtection #Healthcare #GDPR #EUDPR #EMA #PatientSafety

The October 2024 FREE PharMarketing GDPR Life Sciences Data Protection, Data Privacy AI #NEWSLETTER has been issued! Subscribe Now: write to: contact@pharmarketing.net Read about the Code of Conduct of the #EUCROF on Clinical Research, 9 #UK toolkits, a Q&A released by the #FDA for ER/ES, #Sri Lanka DPO appointment rules, #Penalties for Non-Compliance with #Health Data #Privacy - and the QUIZ! #dataprotection #GDPR #privacy #lifesciences #regulatoryaffairs #compliance #HIPAA #HEALTHCARE #HEALTHDATA #lifesciences #medicalresearch #clinicaltrials #patientdata #GoodLaboratoryPractices #ich #gxp #GLP #GCP #GMP #ISO27001 #CTR #MDR #IVDR  #drugs #pharmaceuticals #medicaldevices #IVD #diagnostics #EDPB #EDPS #adequacy #authorities #EMA #FDA #ICF #EHDS #HEOR #RWD #RWE #innovation #AI #artificialintelligence

Breaking! #US #Kentucky voted 94-0 a New #Privacy #Law If enacted, it will apply on 1st Jan 2026 Again we see a convergence with #EU #GDPR, as the Bill will require a Data Privacy Impact Assessment #DPIA to be drafted for some #personal #data processings! https://lnkd.in/ehYsEy5Y #dataprotection #GDPR #privacy #lifesciences #regulatoryaffairs #compliance #GDPR #HIPAA #HEALTHCARE #HEALTHDATA #privacy #dataprotection #lifesciences #medicalresearch #clinicaltrials #healthdata #patientdata #GoodLaboratoryPractices #ich #gxp #ISO27001 #CTR #MDR #drugs #pharmaceuticals #medicaldevices #IVD #MDR #EDPB #EDPS #adequacy #authorities #EMA #FDA #ICF #EHDS #HEOR #RWD #RWE #innovation #AI #artificialintelligence #GLP #GCP #GMP

Teasing....Why 86? Is it the year of birth of our Director Caroline Josse? Stay tuned to discover which achievement it represents! PharMarketing GDPR Life Sciences Data Protection, Data Privacy #dataprotection #GDPR #privacy #lifesciences #regulatoryaffairs #compliance #GDPR #HIPAA #HEALTHCARE #HEALTHDATA #privacy #dataprotection #lifesciences #medicalresearch #clinicaltrials #healthdata #patientdata #GoodLaboratoryPractices #ich #gxp #ISO27001 #CTR #MDR #drugs #pharmaceuticals #medicaldevices #IVD #MDR #EDPB #EDPS #adequacy #authorities #EMA #FDA #ICF #EHDS #HEOR #RWD #RWE

📣 Join us tomorrow at Cluj Innovation Days 2024! Contact MyData-TRUST - Data Protection & Privacy for Life Sciences complete solution provider for #dataprivacymatters #gdprcompliance #FADP #hipaa #ukgdpr #pipeda #lgpd dedicated to #biotech #medtech #lifesciences #clinicaltrials #clinicalresearch #clinicaldata

The increasing enforcement of GDPR under the EHDS directly impacts biopharma because their access to health data for research and clinical trials will become more tightly regulated. Without strict GDPR compliance, biopharma companies risk losing access to essential health data, face potential fines, and encounter delays in research. This could hinder innovation, disrupt trials, and reduce investor confidence, ultimately affecting their ability to bring new therapies to market. Compliance will be key to ensuring smooth collaboration and data sharing under the EHDS framework. #GDPRCompliance #EHDS #DataProtection #Biopharma #HealthData #ClinicalResearch #RDPrivacy #InnovationInHealthcare #HealthDataSecurity #PrivacyForResearch #AIinBiopharma #DigitalHealth

European Health Data Space ('EHDS') : What are the Rules on Secondary Use of Health Data? Read in our March FREE #Newsletter on #Healthcare, #Lifesciences and #GDPR! Subscribe at contact (at) pharmarketing.net #dataprotection #GDPR #privacy #lifesciences #regulatoryaffairs #compliance #GDPR #HIPAA #HEALTHCARE #HEALTHDATA #privacy #dataprotection #lifesciences #medicalresearch #clinicaltrials #healthdata #patientdata #GoodLaboratoryPractices #ich #gxp #ISO27001 #CTR #MDR #drugs #pharmaceuticals #medicaldevices #IVD #MDR #EDPB #EDPS #adequacy #authorities #EMA #FDA #ICF #EHDS #HEOR #RWD #RWE PharMarketing GDPR Life Sciences Data Protection, Data Privacy

📐 GRC Infographic  🩺🌡💉Medical Devices 📘 Regulation (EU) 2017/745 : an overview. 📘 The “Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC” defines the rules relating to the placing on the market, making available on the market or putting into service medical devices for human use and accessories for such devices in the European Union. 🩺🌡💉 ⚙️Reg. EU 2017/745 is structured around ten chapters and a series of annexes. 📄 🔏 In particular, the articles referred to in "CHAPTER IX confidentiality, data protection, financing and sanctions" define among the requirements applicable to all parties concerned by the application of Reg. EU 2017/745 also those of the confidentiality of the information and data obtained in carrying out their duties, in order to protect personal data. 💻 #dispositivimedici #medicaldevice #regUE745 #GDPR #privacy #dataprotection