Best Practices for PreSubmission meetings from a TPD

Best Practices for Pre-Submission meetings from a TPD perspective CAPRA Dinner, August 30, 2007 Veronica Yip Senior Regulatory Project Manager, Regulatory Project Management Division Office of Business Transformation, Therapeutic Products Directorate

2 Overview • • Meeting Requests Contents of Pre-Submission Meeting Package Additional Considerations What to expect before the Pre-Submission Meeting • Meeting Conduct • Minutes & Record of Decisions • Our Goal…

3 Meeting Requests • Written request sent to Bureau Director c/o the RPM – Preferrably 6 weeks in advance • Request should include: – – – Background information Clear objectives and expected outcome of meeting Mode of communication to best address questions List of requested HC representatives and industry attendees Draft questions • Be specific and avoid broad questions – 3 proposed dates of the meeting • RPM may request for additional information prior to scheduling the meeting

4 Contents of Pre-Submission Meeting Package • Structure pre-meeting package to achieve the following objectives: – – Submission Planning and Overview Drug Development Issues Driven Meeting Product Monograph/Labeling Discussions • Kept to 1 volume in length (1” binder; ~20 pages for summary document) – references should be relevant – RPMs will contact you if more data is needed

5 Contents of Pre-Submission Meeting Package (cont…) • Cover letter • Proposed Agenda for the meeting • Draft slides • List of sponsor representatives who will attend meeting • List of specific issues and/questions seeking HC input • Avoid unanswerable questions • Clearly articulate your position on potential areas of concerns or issues that will be discussed at the meeting • Requests for eligibility to file NDS at the end of Phase II, Priority review, NOC/c, Rx to OTC switches • Proposed and currently approved indication(s), strength(s), dosage form(s), and dosage recommendations • Anticipated global and HC filing date(s)

6 Contents of Pre-Submission Meeting Package (cont…) • Brief summary of the drug product – Drug product development • Information regarding production processes and market formulation (plus changes made) • Information on novel excipients, or APIs of biological origin • Testing methods – Clinical development plan • completed and ongoing CTAs • Identification of gaps and hurdles during drug development • Issues experienced at the present time, and plan or actions to address issue – Safety & efficacy data • Summary of studies with analysis of results presented, analyzed, and synthesized • List of completed and on-going studies (study design, # patients, site(s)) • Outline of remaining studies to be conducted locally or globally – Overview of international market history and correspondence (e. g. , ACM to discuss critical path mechanism, change in clinical end points and/or protocol designs) • Summary of any correspondences with Health Canada during clinical development • Draft Product Monograph and labeling

7 Additional considerations • For drug development focused meetings: – Overview of drug should include MOA, special claims, statement why drug would be significant addition to existing therapy (ies) • For NDS (NCE) focused meetings: – Pre-clinical proof of concept – Safety profile from pre-clinical data – Any concerns from AE’s reported • Any Risk Management (Pharmacovigilance) Plans? • Meeting maybe post-poned or cancelled if the pre-submission meeting package is not provided within the specified timeframes given by TPD; or is considered to be incomplete.

8 What to expect before the Pre-Submission Meeting • Pre-Submission Meeting package should be received 4 weeks in advance by TPD • SIPD -> RPMD -> package distributed to HC meeting attendees • Internal Prep. Meeting scheduled to discuss meeting package – – – Get the right people for the meeting Background analysis Focus on addressing sponsor’s list of questions Identify any gaps or outstanding issues that should be discussed at meeting Generate HC’s list of questions to be shared with sponsors, based on pre-submission meeting package contents • Address at the pre-submission meeting, or prior to filing Discuss any modifications to the proposed agenda • HC provides comments on the briefing package in advance of meeting • Enhanced communication – – • Internal/external expectations More value-added to TPD and sponsor Finalize Agenda and Slides in advance of Pre-Submission Meeting

9 Meeting Conduct • Stay focused on the agenda – Be conscious of the time • Issue focused meeting – less emphasis on overview presentation • Limit presentation to 20 - 30 minutes – Allow for more time for discussion – List of Questions provided to TPD • Open & Transparent Discussion – Minimize Surprises – Share your concerns and propose solutions • Minimize “off-line” discussions • At the end of the meeting, summarize the outcomes, commitments, and action items

10 Minutes & Record of Decisions • Responsibility lies with meeting requestor to take minutes – – – • Minutes should be reflective of scientific discussion Keep it concise Avoid minutes that are verbatim of the discussion Highlight outcomes, commitments, action items Keep tone neutral Current Practice: – Draft minutes prepared by sponsor and forwarded to HC via the RPM within 2 wks – Minutes accepted by HC or further modifications sent to Sponsor for review. – Sponsor to review changes for acceptability Suggestion: – Each party can elect to take their own minutes (Laptop, hand written) – Official proceedings captured in ROD with both parties in agreement prior to leaving the meeting – Timely, efficiencies gained, clear expectations • Final Meeting minutes, as well as any post-meeting correspondences (hard copy & electronic version) included in submission under Module 1

11 Our Goal… • Characterized by transparency and openness • TPD proactively provides advice/guidance – Don’t shop around for answers – We may request for additional post-meeting information • Not all Bureau/Divisions work identically – Number of meetings per month – Ask the RPM • Welcome and encourage innovative solutions and strategies • Share best practices

12 Thank you for your attention. Questions? Should you have any questions, please contact: Veronica Yip Senior Regulatory Project Manager Office of Business Transformation Therapeutic Products Directorate Health Canada Tel: (613) 954 -6481 Fax: (613) 952 -9310 Email: Veronica_Yip@hc-sc. gc. ca