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Transcript of Centralized Procedure CHMP/EMA. tony humphreys.pdf · Centralized Procedure CHMP/EMA ... - Oral...
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Centralized ProcedureCHMP/EMACHMP/EMA
• Overview of CHMP Operations
DIA E R lDIA European Regulatory Affairs Forum
01-02 June 2010London, UK
Anthony HumphreysHead of Regulatory, Procedural and Committee Support London, UK
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Disclaimer
The views and opinions expressed in the following PowerPoint slidesare those of the individual presenter and should not be attributed toDrug Information Association, Inc. (“DIA”), its directors, officers,employees, volunteers, members, chapters, councils, Special InterestA C iti ffili t i ti ith hi h thArea Communities or affiliates, or any organization with which thepresenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the individualpresenter and are protected under the copyright laws of the UnitedStates of America and other countries. Used by permission. All rights
d D I f ti A i ti DIA d DIA lreserved. Drug Information Association, DIA and DIA logo areregistered trademarks or trademarks of Drug Information AssociationInc. All other trademarks are the property of their respective owners.
2www.diahome.orgDrug Information Association
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Drug Information Association www.diahome.org 3
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Meeting Logistics
11 Plenary Meetings / year Satellite meetings:11 Plenary Meetings / year
Monday: 09.30 – 19.30Tuesday – Wednesday: 08 30 - 20 30
Satellite meetings:
DG’s/Briefings/NCA ConsultationTuesday – Wednesday: 08.30 - 20.30
Thursday: 08.30 - 16.00
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Meeting LogisticsMeeting Logistics
11 Meetings / yearDates set and published up to 5 years in advance
Submission dates / Response Timetables etc… set, based on CHMP Meeting d t
http://www.ema.europa.eu/htms/human/presub/q25-2.htm
datesNo meeting in August – replaced by written procedure (timetables / letters for information etc… – no opinions adopted)Extraordinary meeting whenever is neededExtraordinary meeting whenever is needed
Paperless meeting!Paperless meeting!- Agenda and Minutes circulated in paper- Oral Explanation slides provided by company- All other documents via MMD (Managing Meeting Documents)
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Centralized procedure Primary Driver dictating timing Plenary meetingsPlenary meetings
= Adoption LOQ 120* Start of procedure
= Adoption LOQ 180* Submission of responses
= Adoption Opinion 210* Timing of oral explanation* Timing of oral explanation
= Post Authorisation Variations
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Icelandic Volcano
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Meeting Room
Customised Meeting Room
= VDU / 2 seats
= MMD System = meeting documents
= Voting software trends/final votes
= WIFI
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CHMP Seating Plan Under Spain Presidency
x
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Who is Invited to the CHMPWho is Invited to the CHMP
All CHMP members/alternates invited
All CHMP members plus alternates with responsibility for items
on the agenda or replacingon the agenda or replacing
member for that meeting are reimbursed
SAG Chairpersons reporting on outcome of SAG meeting
Working Party Chairpersons (for ORGAM section) are reimbursed
N = 70-90CHMP
Working Party Chairpersons (for ORGAM section) are reimbursed
We don’t reimburse invitations for:Experts accompanying Rapporteurs for specific productAlternates who do not have any key items on agenda (invited to attend at own expense)
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Remote Access
EMA Secretariat – live intranet b d tbroadcast
No permanent recordNCA Assessors / Experts - telecon
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Agenda
• May 2010 Meeting Agenda107 pages (revision 4)
• Time schedule35 main 72 annex
• Time schedule » Established Pattern» Flexibility required
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Agenda Main – I. For Adoption
I.1 Agenda I.2 MinutesI.3 Opinions
New MA/II indications/II safety (controversial)Annual re assessments/renewals ++Annual re-assessments/renewals ++
I.4 List of QuestionsList of Outstanding IssuesgRequest for Supplementary Information
I.5 Re-examination Procedures Suspensions / Withd lWithdrawals
I.6 Referrals
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Agenda Main – II. Pharmacovigilance
II. PharmacovigilanceII. Pharmacovigilance
II.1 Report for the PhVig Working PartyII.2 Pharmacovigilence Issues
E l N tifi ti S t» Early Notification System» Product Specific Follow Up
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Agenda Main – III and IV
III. Oral Explanations (mixed procedures)
IV Other Product Related Issues/InspectionsIV. Other Product Related Issues/InspectionsIV.1 Pre + Post Submission Issues
Eligibility / Rapporteur /Eligibility / Rapporteur / Post-Authorization Issues
IV.2 Inspections gxp / Pharmacovigilance Inspections
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Agenda Main – V. Scientific Advice / Working Parties / ICH
V. Scientific Advice / Working Parties / ICHg
V.1 Scientific AdviceV.2 Working Parties V.3 SAGsV 4ITFV.4ITF
VI. Sattelite Groups / Other CommitteesCMDh / CXMP’s /NRG
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Meeting Organization
Centralized ProcedureAudits / Improvement
Actions
ORGAM TransparencyORGAMLegislation Implementation /
Preparation Pharmacovigilance
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Miracle of Time schedule
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The Miracle of the Time schedule
MondayIII. Preparation for oral
TuesdayIV. Post-authorization Issuesp
explanationsV. WP ReportsI New applications Opinions
I.4 Log RSI LoOI’SLunch time
I. New applications OpinionsLunch time
III O l E l ti I 4 Log RSI LoOI’SIII. Oral ExplanationI.5 Article 20I.6 Referrals
I.4 Log RSI LoOI SI.6 Referrals
ORGAMI.3 II OpinionsI.4 RSI IIIV Eligibility
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IV. EligibilityV. SAWP Report
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Wednesday ThursdayII. ENSIII. Oral Explanation I.6 Referrals
“Wrap-up” Adoption SlotIV. Presubmission / Post-
Authorisation
I.5 Article 20III. Oral ExplanationI 4 LoQ
V. ORGAMLunch time
I.4 LoQLunch time I.4. Preparation for June 2010
(key identification potential for oral )III. Oral Explanation
II. Pharmacovigilanceexplanation)
IV.2. GXP Inspections
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Post Meeting documents Post Meeting documents PublicPublic
CHMP Press Release: Created by Press Office and published on last day of Meeting
- Product related issues only Product Press Releases Questions and Answers documents EPARsProduct Press Releases, Questions and Answers documents, EPARs etc…
- Responsibility of individual PTLs
CHMP Monthly Report: Created by CHMP Secretariat and published
a week after CHMP
- Products and non products related issues
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CHMP Member Endangered Species?
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Rapporteur
<FPP>
Rapporteur
Referrals
Rapporteur
<NFPP>
CHMP
Member
PEER
Reviewer
Appointed
PEER
Reviewer
GeneralAppointed General
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Responsible forResponsible for
Scientific Assessment Team
Rapporteur RoleProvide objective
Scientific opinion
Co-ordinate
Input
WP/AHeg/SAG
Conferences
Involve
additional
expertise as
necessaryp
Identify
Conditions
Act CHMP
Representative
For MA + PAM
p
Liaison
Applicant/MAH
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Voting at the CHMPVoting at the CHMP
• Quorum required for adoption of opinions: two thirds of total members eligible to q p p gvote (22)
• Positive or negative votes – abstention not possible
• Where possible, opinions should be taken by consensus. Where consensusWhere possible, opinions should be taken by consensus. Where consensus cannot be reached, opinion adopted by absolute majority of members (favourable votes by at least half the total members eligible to vote plus one - 17). Divergent position appended to opinion. Need to record names of those expressing divergent opinionopinion
• Norway and Iceland can vote but their votes are recorded separately and not counted in reaching the Committee’s opinion
In case of no absolute majority Committee’s position is deemed to be negative• In case of no absolute majority, Committee’s position is deemed to be negative
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Oral ExplanationsOral Explanations
CHMP Oral Explanations 2001/2009
5862
70 2001
2002
37
31 31
47
50
602003
2004
20053129
15
28
30
40 2005
2006
2007
0
10
202008
2009
0
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Timing of Oral Explanations
Anything from 1 – 9 Oral Explanations per meeting
Scheduled for Monday - Wednesday afternoon depending on number of oral explanationso o a e p a at o s
Procedures going for opinion at same meeting are given priority
Slots may be requested in advance of meeting – CHMP Secretariat attempts to juggle time schedule
Oral Explanation may be cancelled at last minute, if CHMP decides it is no longer necessaryis no longer necessary
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Internal InformationCascade
AssessmentTeams
AdvisoryCommitteesoperations
National Responsibilities
Line manager
operations
etc
Role NCA
Communication
etc
Communication
Reporting +B i fiPlanning
Input
Availability
Briefings:
HMA, MAH
External
Communications
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Working Parties
Related committees
PDCO/CAT (N=8)
COMP (N=2)
Articles/
Conferences
Parties
Member/Chair
HMPC
Scientific
Advisory Education/Other
Advisory Groups
Education/
trainingDuties
SAWPSpecial
Projects
SPC
Process
Improvement
e.g. SPC
Harmonisation
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Thank you