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07.03.2011
Meetings with Swissmedic
4th SwAPP Experts Exchange Expertise Meetings
Thursday, March 3, 2011
Dr. Urs Kopp, Swissmedic
Swissmedic • Swiss Agency for Therapeutic Products • Hallerstrasse 7 • CH-3000 Bern • www.swissmedic.ch
How to find the documents…
www.swissmedic.ch
Swissmedic
Documents:
Performance
Human medicines
Legal basis
(and Forms and
Checklists)
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Administrative ordinances found:
Scientific Advice
Pre-Submission
Clarification
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But some forms as well:
Forms and Checklists
Forms the same for all 3
meeting types
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Process (shared between 3 versions)
Apply for meeting: turn in form to Case Management
Define Meeting type
Define Questions
fivefold and electronic
Check the number of questions to be reasonable for an (max.) 1.5
hour meeting
Propose some dates for meeting (next 4- 8 weeks)
Decision sent to applicant (if denied Swissmedic includes
reasons)
Internal team meeting – decide on date and preparatory work
Meeting at Swissmedic (or Phone / Video) (cf guidelines)
Minutes proposed by applicant and revised / rectified by
Swissmedic
Invoice SM (200 CHF / working hour / per involved Swissmedic
expert)
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Aim
Similar to EMA guidelines and system
Easy to understand 3 guidelines
Larger parts of these 3 guidelines are similar
Make a more systematic approach
To encourage us to meet industry
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interests
Backstage:
•Finances?
•Willingness?
Civil
Coordinationservant
as
meetings
mechanisms
advisor
science
policy
Frontstage:
•Presentation?
knowledge
CONFLICTS
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Only one of many sources for advice!
The Media
The Internet
Personal study
Personal Contacts
Patient organizations
Universities
Lobbyists
Politicians
Offices
Foreign Consultants
Foreign Governments
International Bodies such
as WHO, ICH, ….
WHO close to declaring swine flu a pandemic
by Rich Bowden - Jun 11 2009, 03:40
Img: WHO headquarters, Geneva. Credit: Yann Forget
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Scientific Advice
22nd Annual EuroMeeting Plenary, 8 March 2010, Monaco:
„The process to develop new medicines and bring them to patients is
neither efficient nor effective“:
⇒
make better use of scientific advice and meetings between
regulators and industry (E. Abadie, Head CHMP)
Before final development or evaluation (e.g.
clinical study design, PV-plan CH, …)
The definition of the problem will be the focal
point of all your problem-solving efforts!
Gather facts
Reverse the Problem / “Front”
Advice = Not a decision!
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Advantages:
Fewer failure due to insufficient adherence to
regulatory principles in the clinical development
Clinical endpoint indications
Insufficient or irrelevant clinical effect or
unfavorable safety
Extrapolation (or not!) to other patient groups
Biotech: quality / manufacturing variations (CMC)
Will not prevent you from a negative decision but
reduces the risk
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Hints for the meeting:
DO‘s
You are the owner of the data –
take all of them into account and
discuss based on them
Focus on science and regulatory
principles
Listen to and understand the
position of the agency
Open to compromise (even after
the meeting)
Ensure that the scientific advice
is well understood
Limited number of attendees
that have the necessary
background
DON’T’s
Expectation that you are the
only owner of the data and
nobody else understands
Scientific reference to the
position of the EMA / FDA /…tell
us!!, tell us differences, but no
general reference (“but XY.. has
approved”)
Argumentation without taking
the point of the agency
Use of internal abbreviations
Using Marketing arguments
instead of scientific view for the
drug
Ask for approval
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Competition….
is welcome!
outcome likely to be
different
enhances chances of
success
tell us differences
(advice / guidelines) –
ask for opinion
accept limited capacity
of Swissmedic
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Pre-Submission Meeting
6 – 12 months before submission of the application
Questions as:
How to prepare documentation
What legal basis is applicable for the product
§13 LTP
…..
NOT is the product approvable (we tell after assessment)
NOT how do I need to apply in CH for XY (go to a consultant)
Cf for eCTD: Trial submission can be done
Written answer if more effective
Attendees: regulatory experts
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Clarification Meeting
After List of Question received by applicant
Questions in writing on:
How to understand SM questions (rephrasing / restating
observation)
Patient groups / Clinical use
Strategy for responses to SM questions
Rough time estimate depending on strategy / additional data
NOT final labeling decision
NOT final decision and failure risks
Attendees: Scientists / Clinicians
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Swissmedic experience
Roughly 40 meetings in 2009
SM in general happy with the meetings
Workload as an issue
As the number of fulltime-experts at Swissmedic
is limited we sometimes get support by our
expert committee
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Annual
Report
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Your chance!
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