
2nd ICHE6(R3)
September 5, 2024 – Virtual Event
What Clinical Operations and Quality Professionals Need to Know Now to Ensure Compliance
Previous Attendees






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Target Audience
This event is tailored for executives involved in any promotional campaign within a life sciences organization.
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Networking
Join this event to connect with leading professionals driving progress in promo review.
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Program Design
Each Momentum event is designed through a proven research and design methodology that has been behind some of the pharma industry's largest events.
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Featured Speakers
Meet the Minds Behind Our Awesome Event

Dave Nickerson
Head, Clinical Quality Management
EMD SERONO
Member of E6(R3) Expert Working Group

Janette Panhuis
Principal Consultant
Quality Matters

Paula Walker
Global Head Risk Based Management
ROCHE
Former Head of Compliance, MHRA

Louise Mawer
GXP Auditor and Trainer
Mirabilitas Ltd

Cheryl McCarthy, RQAP-GCP, CQA, CMDA.
Experienced GCP/Quality Professional
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Program Agenda: Day One
September 5, 2024
10:00am - 10:15am EDT
Welcome and Introduction
Available On-Demand - Must Participate LIVE to Engage with Speakers
10:15am - 10:45am EDT
THE PURPOSE OF ICH E6 REVISIONS AND UPDATE ON FINALIZATION
Speakers
Dave Nickerson
Head, Clinical Quality Management
EMD SERONO
Member of E6(R3) Expert Working Group
Available On-Demand - Must Participate LIVE to Engage with Speakers
10:45am - 11:15am EDT
PROPORTIONATE RISK-BASED APPROACH
Speakers
Paula Walker
Global Head Risk Based Management
ROCHE
Former Head of Compliance, MHRA
Available On-Demand - Must Participate LIVE to Engage with Speakers
11:15am - 11:45am EDT
SPEAKER Q&A: FACE-TO-FACE ENGAGEMENT VIA ZOOM
Speakers
Dave Nickerson
Head, Clinical Quality Management
EMD SERONO
Member of E6(R3) Expert Working Group
Paula Walker
Global Head Risk Based Management
ROCHE
Former Head of Compliance, MHRA
Must attend LIVE (Not Recorded)
11:45am - 12:15pm EDT
30-Minute Break
12:15pm - 1:00pm EDT
DATA GOVERNANCE
Speakers
Janette Panhuis
Principal Consultant, Quality Matters
Available On-Demand - Must Participate LIVE to Engage with Speakers
1:00pm - 1:45pm EDT
ESSENTIAL RECORDS AND TMF
Speakers
Louise Mawer
GXP Auditor and Trainer, Mirabilitas Ltd
Available On-Demand - Must Participate LIVE to Engage with Speakers
1:45pm - 2:00pm EDT
15-Minute Break
2:00pm - 2:45pm EDT
SPONSOR OVERSIGHT
Speakers
Cheryl McCarthy, RQAP-GCP, CQA, CMDA.
Experienced GCP/Quality Professional
Available On-Demand - Must Participate LIVE to Engage with Speakers
2:45pm - 3:45pm EDT
CONCLUDING PANEL: HOW TO PREPARE
Speakers
Michele Weitz
Principal
GCP Vision
Louise Mawer
GXP Auditor and Trainer
Mirabilitas Ltd
Cheryl McCarthy, RQAP-GCP, CQA, CMDA.
Experienced GCP/Quality Professional
Available On-Demand - Must Participate LIVE to Engage with Speakers
3:45pm - 3:45pm EDT
Event Concludes
Program Agenda: Day One
October 13th
10:00AM
Welcome
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10:00AM
Welcome
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10:00AM
Welcome
Master cleanse kombucha tumeric brooklyn whatever selvage, portland quinoa. Austin mlkshk pour-over kickstarter beard, put a bird on it palo santo lomo single-origin coffee master cleanse fashion axe keffiyeh hexagon art party activated charcoal.
10:00AM
Welcome
Master cleanse kombucha tumeric brooklyn whatever selvage, portland quinoa. Austin mlkshk pour-over kickstarter beard, put a bird on it palo santo lomo single-origin coffee master cleanse fashion axe keffiyeh hexagon art party activated charcoal.
10:00AM
Welcome
Master cleanse kombucha tumeric brooklyn whatever selvage, portland quinoa. Austin mlkshk pour-over kickstarter beard, put a bird on it palo santo lomo single-origin coffee master cleanse fashion axe keffiyeh hexagon art party activated charcoal.
10:00AM
Welcome
Master cleanse kombucha tumeric brooklyn whatever selvage, portland quinoa. Austin mlkshk pour-over kickstarter beard, put a bird on it palo santo lomo single-origin coffee master cleanse fashion axe keffiyeh hexagon art party activated charcoal.
10:00AM
Welcome
Master cleanse kombucha tumeric brooklyn whatever selvage, portland quinoa. Austin mlkshk pour-over kickstarter beard, put a bird on it palo santo lomo single-origin coffee master cleanse fashion axe keffiyeh hexagon art party activated charcoal.
10:00AM
Welcome
Master cleanse kombucha tumeric brooklyn whatever selvage, portland quinoa. Austin mlkshk pour-over kickstarter beard, put a bird on it palo santo lomo single-origin coffee master cleanse fashion axe keffiyeh hexagon art party activated charcoal.
Pricing
Advanced Price
Better book soon!
$1895
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Frequently Asked Questions
-
1. Why Should I Attend? (aka: What's In It for Me?)
TOP REASONS TO ATTEND
- Breakdown the fundamental concepts of ICH E6(R3) to understand how it builds on R2 and E8 by driving critical thinking and paves the way for innovation
- Learn how to define risk and identify critical to quality (CtQ) factors to build a proportionate risk-based approach
- Gain confidence to stop trying to achieve perfection by recognizing that it’s thwarting your ability to protect what matters most
- Recognize that R3 allows for rapid technological adoption and advancement with a heavy focus on data governance
- Understand how to build quality and critical thinking into all aspects of trial design and execution
-
2. Who Should Attend? (Hint: It Might Be You)
WHO SHOULD ATTEND
This event is developed for professionals from pharmaceutical, biotechnology and medical device companies, CROs, clinical service and technology providers as well as those professionals from sites who have responsibilities in any the following areas:
- Inspection/ Inspection Readiness
- Compliance/ Clinical Compliance/ Regulatory Compliance
- Auditing
- Quality Management/ Clinical Quality Management
- Clinical Quality Assurance/ QA/ CQA
- Clinical Quality Control/ QC/ CQC
- Quality Operations/ Quality Systems/ Quality Processes
- Regulatory Affairs
- Clinical Operations/ Management/ Research/ Development
- Clinical Outsourcing/ Vendor Oversight and Management/ Strategic Partnerships/ Third-Party Management and Oversight
- Clinical Risk/ Quality Risk/ Risk Assessment/ Risk Management
- Site Monitoring/ Site Management/ Study Management/ Trial Management
- Good Clinical Practice/ GCP
- Clinical Data
-
3. Can I Register a Group? (Squad Goals: Activated)
Yes! Bring your crew. Whether it’s your department, your leadership team, or your whole company — group registration is easy and comes with perks. Discounts? You bet. Better collaboration back at the office? Definitely. Reach out to us for custom group packages and let’s make it a team experience.
CROSS-FUNCTIONAL TRAINING – DEEP DISCOUNTS FOR GROUPS
Many attending companies from 2023 sent cross-functional groups and have already registered additional teams for this next iteration. For more details contact solange@momentumevents.com.
-
4. What’s the Event About? (The Elevator Pitch)
This is a MAJOR EVENT in GCP!!!!
The long-awaited draft version of ICH E6(R3) was published on May 19, 2023, and it’s a doozy, a whopping 80 pages! With the final version of this critical document that modernizes clinical research, soon to be released, the TIME to prepare is NOW!
Haven’t had time to read it yet? You are not alone.
Attend this One-Day Summary Instead!
We’ve conducted extensive industry research to identify the sections of ICH E6(R3) that significantly changed from R2 and have the greatest impact on clinical operations and quality teams. This one-day virtual experience on Thursday, September 5, summarizes how these sections of E6 have evolved and what you need to do NOW, to be ready for compliance.
Our inaugural event in September 2023 attracted 80+ Participants with 78% representing trial sponsors.
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5. Where's the Event? (Location, Location, Inspiration)
VIRTUAL EVENT
Momentum’s Virtual Event has been designed to achieve every single conference objective – minus the impossible, the handshake. Designed on the latest technological platforms, and seamlessly integrated with Momentum’s best in class infrastructure, attending a Momentum Virtual Event will be the next best thing to sitting in the conference session. To find out more about hosting your own VE, email ve@momentumevents.com
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6. Interested in Sponsorship? (Let’s Talk Visibility + Value)
2024 SPONSORSHIP OPPORTUNITIES ARE OPEN
Sponsorship is a great way to enhance your brand’s visibility and help you connect with top-level decision-makers, innovators, and industry disruptors. There are a number of ways to maximize branding opportunities at the summit.
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7. How Do I Network? (Spoiler: It’s Easier Than You Think)
We make networking feel natural — not awkward. From structured roundtables and topic lounges to networking receptions and interactive sessions, there are plenty of ways to meet people who matter to your work (and might just become collaborators or friends). Just bring your curiosity — we’ll handle the rest.

Frequently Asked Questions
-
What are the top reasons why I should attend?TOP REASONS TO ATTEND
- Breakdown the fundamental concepts of ICH E6(R3) to understand how it builds on R2 and E8 by driving critical thinking and paves the way for innovation
- Learn how to define risk and identify critical to quality (CtQ) factors to build a proportionate risk-based approach
- Gain confidence to stop trying to achieve perfection by recognizing that it’s thwarting your ability to protect what matters most
- Recognize that R3 allows for rapid technological adoption and advancement with a heavy focus on data governance
- Understand how to build quality and critical thinking into all aspects of trial design and execution
-
Who should attend?
This event is developed for professionals from pharmaceutical, biotechnology and medical device companies, CROs, clinical service and technology providers as well as those professionals from sites who have responsibilities in any the following areas:
- Inspection/ Inspection Readiness
- Compliance/ Clinical Compliance/ Regulatory Compliance
- Auditing
- Quality Management/ Clinical Quality Management
- Clinical Quality Assurance/ QA/ CQA
- Clinical Quality Control/ QC/ CQC
- Quality Operations/ Quality Systems/ Quality Processes
- Regulatory Affairs
- Clinical Operations/ Management/ Research/ Development
- Clinical Outsourcing/ Vendor Oversight and Management/ Strategic Partnerships/ Third-Party Management and Oversight
- Clinical Risk/ Quality Risk/ Risk Assessment/ Risk Management
- Site Monitoring/ Site Management/ Study Management/ Trial Management
- Good Clinical Practice/ GCP
- Clinical Data
-
Can I register a group?
We offer group discounts for teams attending the conference, providing a valuable chance to connect with remote colleagues.
-
What is the Event About?
This is a MAJOR EVENT in GCP!!!!
The long-awaited draft version of ICH E6(R3) was published on May 19, 2023, and it’s a doozy, a whopping 80 pages! With the final version of this critical document that modernizes clinical research, soon to be released, the TIME to prepare is NOW!
Haven’t had time to read it yet? You are not alone.
Attend this One-Day Summary Instead!
We’ve conducted extensive industry research to identify the sections of ICH E6(R3) that significantly changed from R2 and have the greatest impact on clinical operations and quality teams. This one-day virtual experience on Thursday, September 5, summarizes how these sections of E6 have evolved and what you need to do NOW, to be ready for compliance.
