Pre Conference Workshops

09:00 AM : 09:30 AM

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Registration & Welcome

09:30 AM : 10:30 AM

Session 1

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Audits & Inspections in Pharmacovigilance: Trends & Readiness

11:00 AM : 11:30 AM

Session 2

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Patient Advocacy & Centricity: Bridging the Safety Disconnect

11:30 AM : 11:45 AM

Session 3

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Group Allocation & Instructions

11:45 AM : 12:45 PM

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Lunch Break

12:45 PM : 01:00 PM

Session 4

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Mock Inspection Briefing

01:00 PM : 02:15 PM

Session 5

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Mock Inspection Simulation – Live Roleplay

02:15 PM : 02:45 PM

Session 6

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Debrief & Inspection Feedback

02:45 PM : 03:00 PM

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Tea Break

03:00 PM : 04:00 PM

Session 7

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Group Brainstorm & Presentations

04:00 PM : 04:45 PM

Session 8

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Expert Panel Reflections & Key Takeaways

04:45 PM : 05:00 PM

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Workshop Wrap-Up & Close

10:00 AM : 10:30 AM

Session 1

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Introduction to ISCR and MW Workshop

10:30 AM : 12:00 PM

Session 2

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Strategic and tactical publication planning in evolving clinical landscapes

12:00 PM : 01:00 PM

Session 3

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From data to draft – writing with impact

01:00 PM : 02:00 PM

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Lunch Break

02:00 PM : 03:00 PM

Session 4

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From data to draft – writing with impact

03:00 PM : 03:20 PM

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Tea break

03:20 PM : 04:50 PM

Session 5

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Maximizing reach and engagement beyond the manuscript

04:50 PM : 05:00 PM

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Summary and closing remarks

09:00 AM : 09:15 AM

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Welcome & Introduction
Workshop objectives and agenda overview

09:15 AM : 10:30 AM

Session 1

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ICH-GCP E6(R3) Refresher: Investigator Oversight and CRC Role

10:30 AM : 11:00 AM

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Tea Break

11:00 AM : 12:00 PM

Session 2

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12:00 PM : 12:45 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE

12:45 PM : 01:30 PM

Session 4

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Source Documentation & Case Report Form (CRF) Completion

01:30 PM : 02:30 PM

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Lunch Break

02:30 PM : 03:00 PM

Session 5

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Investigational Product (IP) Management & Accountability

03:00 PM : 03:45 PM

Session 6

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Practical Aspects of Safety Reporting

03:45 PM : 04:15 PM

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Tea Break

04:15 PM : 05:00 PM

Session 7

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Communication & Empathy: Essential Soft Skills for CRCs

05:00 PM : 05:30 PM

Session 8

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Clinical Trial Agreement (CTA) & Budget Essentials (CRC Perspective

05:45 PM : 06:00 PM

Session 9

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Q&A, Key Takeaways & Closing Remarks

Main Conference Tracks

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

09:00 AM : 01:00 PM

Session 1-3 Common Sessions Across All Tracks

0 : 0

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

09:00 AM : 01:00 PM

Session 1-3 Common Sessions Across All Tracks

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 05:30 PM

Poster Presentations & Assessments (in parallel to all ongoing tracks)

02:00 PM : 04:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Strategic role of medical writers in leading submissions
Strategic Role of Lead Medical Writers in Accelerating Clinical Development
Briefing Books–Strategic Communication between the Sponsor and Health Authority in Drug Development
IND Briefing documents
Accelerating Regulatory Approvals: How Lean Writing & Structured Content Authoring Drive Faster, Patient-Focused Clinical Research

Main Conference Tracks