Upload
felicia-cole
View
214
Download
0
Embed Size (px)
Citation preview
Madrid, 28- Marzo-2012
L.Briones, PhD, MBA. BIO ROI Consulting SL. 1
ATIMPsGOOD CLINICAL
PRACTICE
Lola Briones, PhD, MBABIO ROI Consulting [email protected]. 639 83 31 61
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 2
Detailed EU guidelines on GCP specific to ATMPs ENTR/F/2/SF/dn D(2009) 35810, 2009
04/21/23 Perfil de compañía 2
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 3
ATIMPs GCP 2009 Introduction
• Specific ATMPs GCPs required• Regulation(EC) 1394/2007 on ATMPs• Supplements E6-ICH GCP on IMP (1996)
• WMA Helsinki Declaration 1964 (Seul 2008)• Pending final adoption
• ATMPs vs ATIMPs• Advanced Therapies Investigational Medicinal
Product
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 4
ATIMPs GCP 2009 content
• Donation, Procurement & Testing
• Tissue/Blood Establishments & Animal Facilities
• Manufacturing & Importation
• Overarching Principles• Traceability• Safety Reporting & Long
Term Follow-up
• National CA• Ethics Committee• Investigator• Sponsor
• Protocol• Investigator Brochure• Essential Documents• Annex-Traceability Records
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 5
ATIMPs GCP 2009: regulationsDonation, Procurement and Testing
of ATIMPsClinical Trials with ATIMP
• Sponsor• Investigator• Manufacturer/Importer
+• Tissue/Blood establishment• Procurement organisations• Animal facilities• Donors
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 6
ATIMPs GCP 2009: regulationsDonation, Procurement and Testing
of ATIMPs• EU Directive 2004/23/EC, Q&S. ( H. cells &
tissues)– EU Directive 2006/17/EC– EU Directive 2006/86/EC
• EU Directive 2002/98/EC, Q&S (H.blood & comp.)– EU Directive 2004/33/EC – EU Directive 2005/61/EC – EU Directive 2005/62/EC
• Donors– EU Directive 2004/23/EC (H. Cells & tissues)– EU Directive 2002/98/EC ((H. Blood & comp.)– Annex 2 GMP/Vol. 4 (animal origin)– CPWP/83508/2009 (xenogenic cells)
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 7
ATIMPs GCP 2009: regulations
Tissue or Blood Establishments and Animal Facilities• Regulations sect. 3
Manufacturing and Importation of ATIMPs• Art. 13, Directive 2001/20/EC
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 8
ATIMPs GCP 2009Overarching Principles
• Traceability• Chain of custody bidirectional links• Follow-up : during & after trial end
– long-term follow-up
• Specifics, ie. Embrionic stem cells; viral vectors, etc
• Specifics: tissues/cells of animal origin• Medical care & decisions-> qualified
Physician/Dentist – Experienced /expert sponsor representative role
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 9
‘… to locate and identify each individual unit of tissue/cell during any step from procurement, through processing, testing and storage, to distribution to the recipient or disposal and vice versa.
… to identify the donor and the tissue establishment or themanufacturing facility receiving, processing or storing the
tissue/cells,
… to identify the recipient(s) at the medical facility/facilities applying the tissue/cells to the recipient(s)
… to locate and identify all relevant data relating to products and materials coming into contact with those tissues/cells
ATIMPs GCP 2009Traceability: the ability to
…
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 10
General requirements• Traceability system in place => bidirectional links
• Accountability• Records: if bankrupct of sponsor ….->-> National
CA• Personal data protection vs subject traceability
Donors code ~ full indentity by tissue/blood establishm. Subject code ~ full indentity by investigator/ institution
ATIMPs GCP 2009Traceability
donoranimal source
donation product subject
Tissue establishmentAnimal facility
Manufacturingsite
Investigator /Institution
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 11
Responsibilities• Sponsor: system in place, contractual
agreements,…• Tissue /blood establishment, procurements• Manufacturer of the ATIMP• Investigator/Institution
– Investigator / Pharmacist / others– Traceability system al clinical site
Archiving• All parties• > 30 years ~ through contractual agreements
ATIMPs GCP 2009Traceability
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 12
Clinical Trials-> E2a ICH (1994) Clinical Safety Data Management, Def. and Standards for Expedited Reporting Guideline
+ Notification of Adverse Events and Reactions+ SAEs associated with trials procedures+ Significant hazards to the subject
+ Sponsor: information/training to the investigatorAE related to product application processInfectionsRe. to product failure (including lack of efficacy)Unexpected reactions: ie. InmunologicalsRe. to Mandatory concomitant medicationsRe. to Medical devices (combined ATMIP)
+ Causality assesment, protocol, AE Reporting Plan
ATIMPs GCP 2009Safety Reporting & Long-Term
Follow-up
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 13
Follow-up ~ sponsor• Need, duration and nature• Risk annalysis strategy• Risks for close contacts and offspring• Follow-up for
– protection of the subject– specific data collection
• Subject Alert Cards, during & after the End• End of Trial definition ~ protocol• Follow-up, part or not of the clinical trial• Subjects withdrawal, follow-up subject to consent
ATIMPs GCP 2009 Safety Reporting & Long-Term
Follow-up
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 14
National CA evaluation• + strategy for traceability, Follow-up, End of Trial
definition and risk-assesment
Ethics Committee evaluation• Traceability vs personal data protection• Close contacts and offspring follow-up• Written Informed Consent• Representative of the sponsor in some processes• Irreversible nature of certain ATIMPs • Protection, donor from sibling/parent pressure
ATIMPs GCP 2009National CA - Ethics Committee
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 15
• Traceability at clinical site• Keep records of traceability • Specific AE & AR • Knowledge of risk annalysis• ATIMP accountability• ATIMP conditions of use, application, …• Requirements and training of other professionals• Inform the subject /legal representative
– Special ATIMP risks and precautions– Guidance on how to communicate risks to close contacts..– …..
ATIMPs GCP 2009Investigator
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 16
• Traceability system• Keep their part of records• Implement AE-AR reporting process• Ongoing risk analysis• Combined products, risks• Identify clinical, safety or efficacy follow-up• Requirement for standardisation of surgical
procedures• Train the investigator:
– ATIMP handling, storage,…– Concomitant therapy, surgical procedures, …
ATIMPs GCP 2009Sponsor
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 17
Protocol. Section # 6 ICH GCP + …….• Flexibility: variability in nature of ATIMPs, diseases• Donor type, material suitability• Medical device, if combined therapy• Blinding issues, preparation vs administration • Traceability system // Safety reporting• End of Trial definition // Follow-up strategy• Subject withdrawal• Specifics, concomitant therapies, surgery,• Representative of the sponsor• Gene therapy
ATIMPs GCP 2009Protocol – Investigator
Brochure
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 18
ATIMPs GCP 2009 Essential Documents
• Traceability records: > 30 years • Each party, information for bidirectional
traceability– Before the Clinical Phase of the Trial– During the Clinical Conduct– After Completion or Termination of the Trial
Investigator/InstitutionE6 ICH GCP. #8. 3. 21.SUBJECT IDENTIFICATION CODE LIST
ATIMP + records linking Traceable
ATIMP
TraceableATIMP
patient codepatient identificationmedical file
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 19
ATIMPs GCP 2009 Annex- Traceability
records
……….Subject Medical Records• product name/code• trial reference code• trial subject code• administration dates and dose
Madrid, 28- Marzo-2012 L.Briones, PhD, MBA. BIO ROI Consulting SL. 20
THANKS
BIO ROI ConsultingStrategy & Education
[email protected]. + 34 639 83 31 61
ATIMPs GCP 2009