EU Clinical Trials Regulation Regulation EU 536/2014
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1 EU Clinical Trials Regulation Regulation EU 536/2014 María Jesús Zafra Director, QA & Compliance Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 2 1
2 Introduction A Directive is mandatory, aimed at Member States (MS), which must then be transposed into national legislation (1 directive 28 laws) Clinical Trials Directive (CTD) A Regulation is mandatory and self-executing without need for Member State s transposition (1 law at EU level) => New Clinical Trials Regulation (CTR) Page 3 Introduction EU Directive 2001 (2001/20/EC) Diferent interpretation and application between Member States Submission to each Competent Authority (CA) and Ethics Commitee (EC) Increase cost and administrative burdens Delays for launching multinational trials Page 4 2
3 Introduction Most relevant change to CT legislation since the EU was implemented in 2001 Significant change for submission procedures, transparency, simplification New EC CTR will repeal EU Directive Binding for all Member States Page 5 Introduction 99 Articles 7 Annexes: I. Application dossier for the initial application II. Application dossier for substantial modification III. Safety reporting IV. Content of the summary of the results of the CT V. Content of the summary of the results of the CT for the lay persons VI. Labeling of IMP and auxiliary medicinal products VII. Correlation table with EU CTD Covers the full study life cycle Applies to interventional studies Page 6 3
4 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 7 Timelines and main changes Publish notice +3m Results on March m Applicable by Dec 2017 (?) Date of publication + 18 months Delayed to Dec 2020 (?) 28 May 2019 Postponed! Ready for auditing at the end of 3Q May Nov May 2016 EU Portal operational (estimated) Earliest date EU CTR applies New CT submission under current Directive ends Old trials must be transferred to EU Regulation EU CTR Official Publication It will apply as from 6 months after the publication of the notice of successful audit Page 8 4
5 Timelines and main changes Main changes Single entry point for all CTs conducted in Europe: EU Portal EU Database Single authorization procedure for all CTs: Faster assessment by all MS One single outcome More transparency for CTs data Lighter regulatory regime for CTs conducted with medicines already authorized and which pose only minimal risk compared to normal practice Recognized co-sponsorship Page 9 Timelines and main changes Main changes Summary of changes: New CTA submission process throughout EMA portal New class of low interventional CTs Transparency requirements Extension of UK serious breach legislation to all 28 EU countries Aligned safety reporting requirements Clarifications to Informed Consent (emergency setting) Clarification of non IMPs (now Auxiliary Medicinal Products) TMF updates (at least 25 years filing) Additional/changed start-up roles and responsibilities in EU Additional notifications during study life cycle Page 10 5
6 Timelines and main changes EU Portal For submission of ALL documents of CT dossier Via of communication between MS and Sponsor Purpose to coordinate multi-national CTs and streamline deadlines and reporting Requests Member States EU Portal Submission and answer to requests Page 11 Sponsor Timelines and main changes EU Database Keeps track of all records and data in CTs conducted in EU Member States Easier access to the information Citizens can access clinical trials information Page 12 6
7 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 13 Current CTA evaluation procedure (excluding Voluntary Harmonization Procedure) Sponsor MS specific evaluation MS National decision (independent) Submission to each country CA/EC Page 14 7
8 New CTA evaluation procedure Via Portal only Part I: no local country process Part II: review by national EC remains Part I and II can be sequential or in parallel Sponsor PART I (Scientific) 1 Reporting Member State Part I EVALUATION REPORT EU decision Via EU portal PART II (Ethics) Each country Part II MS NATIONAL DECISION Page 15 PART I STUDY SPECIFIC DOCS The concerned MS cooperate in the assessment of scientific, therapeutic and safety aspects PART II COUNTRY/SITE SPECIFIC DOCS The assessment is made by each concerned MS individually and would apply to items such as biological samples, clinical trials agreements, informed consent, recruitment of subjects PART I + PART II Can be reviewed in parallel or alternatively. Part I can be reviewed first followed by part II, depending on the sponsor s preference Page 16 8
9 Review timelines have been established, with a total maximum time of 106 days allowed for the initial submission Advance therapy can take up to 156 days Page 17 Overall timelines: Validation 10 to 25 days (Calendar days) Part I Assessment 45 to 76 days Part II Assessment 45 to 76 days Decision 5 days TOTAL 60 to 106 days Page 18 9
10 Substantial modification timelines: Validation 6 to 21 days (Calendar days) Part I Assessment 38 to 69 days Part II Assessment 38 to 69 days Decision 5 days TOTAL 49 to 95 days Page 19 Notifications via Portal: To notify, WITHIN 15 DAYS, each country of the following: Start of the trial First patient, first visit (FPFV) End of recruitment Last patient, last visit (LPLV) Final end of trial (LPLV, last country) Suspension Temporary halt Early termination Page 20 10
11 Notifications via Portal (cont): Database (within Eudravigilance DB) to notify SUSARs and Annual Safety Reports Detailed SUSARs via Eudravigilance DB within specified timelines Annual Safety Reports via Eudravigilance DB And: These reports are forwarded to the MS All third country inspection reports Page 21 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 22 11
12 Highlights From potential 28 to just 1 Single application Permitted Full regulatory responsibility unless agreed otherwise Cosponsorship Based on the nature of CT Flexible Monitoring Page 23 Highlights SUSARs reported directly to Eudravigilance Results are public Summaries within 1 year CSR to support MA within 30 days of opinion PENALTIES Transparency Safety reporting Reported by the Sponsor to MS through the EU portal within 7 days Serious breaches Page 24 12
13 Highlights More detailed rules on ICF: Cluster trials: simplified process Use of data generated for future CTs Emergency situations Informed consent Specific provisions for pregnant or breastfeeding women taking part in CTs Page 25 Highlights Safety reporting Streamline reporting based on EU centralized database for safety reporting (no longer required to submit identical information to different bodies and MS) Possibility of submitting a single Annual Safety Report in all the investigational products used in one trial Page 26 13
14 Highlights Areas of concerned: IT effort by EMA to meet deadlines Required national legislation to be adapted to fit the new framework, especially the collaboration between CAs and ECs Compatibility of MS IT systems EC approvals have to be gained nationally but within same timeframe Possible workload of Reporting MS Is it possible to ask for a clock stop when responding to questions? Not clear information about submission documents Page 27 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 28 14
15 Impact on company processes Preparation: BD awareness Functional team awareness Functional team impact assessment required for evolution of processes, templates, strategy management and resources Transition plan MS difficulties for implementation Plan Management Follow up of country deliverables New metrics Adapt strategy!! Page 29 Impact on company processes Functional team impact assessment required for evolution of processes, templates, strategy management and resources: Business Development Business Units Start-up Units Medical Writing Safety Clinical Operations Units Quality Legal Page 30 15
16 Impact on company processes What is needed: What will we have: New submission process New requirements/ templates New notifications New requirements in terms of maintenance notifications Impact analysis (functional Units) adaptations (SOPs, Working Instructions, Project Plans, Compliance with new notification requirements) Template adaptations (protocol, EU summary for lay persons) Systems adaptation: New notifications Serious breach notifications, assessment and reporting Internal use of Portal and Database Integration with study management Page 31 Impact on company processes At implementation: Transition period: EU CTD & EU CTR to coexist (Sponsor s choice) Assessment based on country local regulation compliance with EU CTR Operational issues Posting of study results at marketing application stage (Sponsor s responsibility most probably) Page 32 16
17 Impact on company processes Hot topics: Changes in process and procedures Development of new capability Needs cross-functional assessment Creation of new roles Teams training Changes and reconfigurations of existing IT systems Simultaneous start in EU changes in expectations of CROs Needs to manage two Quality Systems if EU CTD & EU CTR coexist? EU CTR timelines not defined re-assessment of projects Pricing impact for global trials? For low-interventional trials? Page 33 Impact on company processes Understand the EU CTR and the impact Expertise and good knowledge of how to implement the regulation could be a differentiator: Detailed discussions with clients New customers? Review costs Opportunities: Differentiated response for proposals (RFP) Page 34 17
18 Table of contents Introduction Timelines and main changes Highlights 5 Impact on company processes 6 Conclusions Page 35 Conclusion UE: IT effort from EMA/MS MS effort to adequate national legislation to Part II evaluation Company: EU CTR impacts on company processes Requires knowledge of new regulation and anticipation Requires close follow-up of the implementation Impact on different company functional groups and CTs implementation strategy Requires to review processes, train personal Page 36 18
19 Thank you! Page 37 19
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