Variations in Regulatory Approaches in Healthcare Sector
Explore how different regulators and standards influence quality management in the healthcare sector, with insights from Rob Wosley and the various governing bodies like HTA, MHRA, and HFEA. Learn about the evolving regulations and standards shaping human application, clinical trials, and QA roles.
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Presentation Transcript
REGULATORS & STANDARDS How Approaches Vary Rob Wosley Quality Manager - South West Peninsula Transplant Service Chair - JACIE Quality Forum UK & Ireland
HTA Designated Individual for Human Application Sector Licence UHP/RCHT Quality Manager South West Peninsula Transplant Service JACIE Quality Management Inspector Introduction and Disclaimer BSBMTCT Executive Committee Quality Representative Chair of UK & Ireland JACIE Quality Forum Governance Consultant for CRGW Phase 1 Clinical Trials Background, with other industry experience in QA roles
Medicines & Healthcare products Regulatory Agency (MHRA) Human Fertilisation and Embryology Authority (HFEA) Human Tissue Authority (HTA) Tissues for Human Application Fertility Preservation* ATMPs Regulators Blood and Blood Products *For the purposes of this presentation Clinical Trials
The Human Tissue Act 2004 Human Tissue (Persons who lack capacity) Regulations 2006 Regulations & Standards - HTA Human Tissue (Quality and safety for human application) Regulations 2007 (and subsequent amendments in 2014/2018/2019) Human Tissue (Quality and safety for human application) Regulations Licensing Standards Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment
The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 GMP Inspectorate The Blood Safety and Quality Regulations 2005 (as amended 2006) Regulations & Standards - MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 GMP Inspectorate Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended 2006 (x2), 2008, 2019) Good Clinical Practice Guide GCP Inspectorate
The Human Fertilisation and Embryology(Quality and Safety) Regulations 2014 (as amended 2018) Regulations & Standards - HFEA HFEA Code of Practice
Self-Assessment Tool Pre-Inspection Dossier Inspection Plan Opening and Closing Meeting Common Themes Site Tour Document & Evidence Review Interviews Draft Report Final Report 90 Days to Close-out CAPA
4 Chapters of Standards Serious Adverse Event Adverse Reaction Reporting Annual Activity Report HTA Standards and Inspections Critical Documents 2-year Review Risk-based Approach Two-year Cycle Microsoft SharePoint for Document/Evidence Upload Two Inspectors Triggered Inspections
Multiple Chapters and Annexes of Guidance Annual Compliance Report MHRA Standards and Inspections (ATMP) Critical Documents 2-year Review Risk-based Approach Two-year Cycle Microsoft SharePoint for Document/Evidence Upload Two or More Inspectors Triggered Inspections
Multiple Chapters and Annexes of Guidance Serious Adverse Blood Reactions or Events Reporting (SABRE) MHRA Standards and Inspections (Blood) Serious Hazards of Transfusion Reporting (SHOT) Annual Compliance Report Critical Documents 2-year Review Risk-based Approach Two-year Cycle Microsoft SharePoint for Document/Evidence Upload Two Inspectors Max* (In My Experience) Triggered Inspections
14 Chapters to Guidance MHRA Standards and Inspections (Clinical Trials) Serious Breaches of GCP or Trial Protocol Reporting Adverse Event or Reaction Reporting Risk-based Approach Two-year Cycle Microsoft SharePoint for Document/Evidence Upload Phase 1 Accredited Centres not Risk-based but still 2-3 year Cycle Triggered Inspections for Serious Breaches
33 Guidance Notes (19 apply to fertility preservation) Serious Adverse Event Reporting HFEA Standards and Inspections Annual Activity Report Critical Documents Annual Review Two-year Cycle Evidence E-mailed to Inspector Triggered Inspections
Self-Assessment Tools Reporting Portals for SAEARs etc What Works Well? SharePoint for Evidence Upload Open Communication with Inspectors Proof-Reading the Inspection Report Two-year Document Review
HTA Newsletter MHRA Mailshots Finger on the Pulse HFEA Clinic Update Keep an Eye on Legislation
Closing Thanks to TG and BC Questions?
