Members can leverage the AQC’s ICH E6(R3) side-by-side comparison resources to support continuous quality compliance:

• INSP 26a- ICH E6(R2) and E6(R3) Comparison – updated!
• INSP 26b- ICH E6(R3) Draft to E6(R3) Final Comparison – new!

AQC members gathered for a meeting on Jan. 28 for an in-depth look at the key changes between the R3 draft and the R3 final version. Members can view the recording in the webinar archive section of the AQC Knowledge Center.

Jan. 28, 2025: AQC MEMBER-ONLY MEETING

Unlocking Insights – Overview of ICH E6(R3) Final Guidance Changes

VIEW RECORDING

An industry-wide webinar was held on Jan. 29, discussing the impact that these regulatory guidance changes have on clinical research organizations. View the webinar recording to learn the key updates to support successful adoption and get ahead of the curve of ICH E6(R3) implementation.

Jan. 29, 2025: INDUSTRY-WIDE WEBINAR

ICH E6(R3) is Here – What You Need to Know

VIEW RECORDING

Stay tuned for additional AQC resources and collaboration opportunities on this important topic to maintain compliance in your clinical trials.

Learn more about the AQC and get involved today

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Published January 2025

The post Dive into ICH E6(R3) with AQC Strategies and Resources appeared first on Avoca, a WCG company.

 Actionable steps for stakeholders include:

1. Emphasizing Critical Data and Processes:
   Identifying the critical to quality (CTQ) factors early can help drive key study activities such as monitoring strategy.
2. Early and Continuous Risk Assessments:
   Risk assessment focused on critical data and processes and shared across all stakeholders – including sites.
3. Preparing Sites for ICH E6 (R3) Changes:
   Sponsors and CROs should be prepared to assist sites in understanding and adapting to the new guidelines.
4. Promoting Cross-Industry Collaboration:
   Encouraging inclusive collaboration that integrates all perspectives for a more comprehensive approach to trial planning and execution.
5. Adopting Flexibility and Innovation:
   Openness to integrating new technologies and methodologies, ensuring they align with maintaining quality and compliance.

Learn more about becoming a member of the AQC with access to over 1,000 leading practices and metrics to stay up-to-date on industry guidances.
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The post Leveraging ICH E6 (R3) to Drive Efficiency in the Clinical Trial Process appeared first on Avoca, a WCG company.

WCG’s Avoca Quality Consortium (AQC) provided comments to the FDA as part of the ICH E6(R3) Draft Guidance public consultation on behalf of our 200+ members. By leveraging the power of the consortium, we united cross-functional feedback, representative of all key stakeholders (Sponsors, CROs, Service Providers, and Sites).

The revision to ICH GCP E6(R3) highlights the importance of proportionality and risk-based approaches with focus on quality while encouraging continued innovation; this is a significant update to the conduct of clinical trials for the industry.

In addition to submitting comments on areas that may warrant additional clarity, we have also highlighted training opportunities that may be critical to the successful implementation of this guidance. We anticipate that robust training will strengthen understanding for individual stakeholders as well as ensure consistency across all clinical trial stakeholders.

The Power of Collaboration – thank you to all our members who contributed feedback!

See the comment submission ››

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Learn more about becoming a member of the AQC and access over 1,000 leading practices and metrics to stay up-to-date on industry guidances.
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Published: September 2023

The post The Power of Collaboration: AQC Submits Comments to FDA for Consideration to Draft ICH E6(R3) appeared first on Avoca, a WCG company.

The striking change is the spirit in which the new set of guidelines is encouraging a shift in mind set in managing quality in clinical trials. ICH E6 (R2) is calling upon legions of drug development professionals to recognize that all risks are not of equal importance from a compliance and quality perspective and the key to effectively achieving quality is through making key decisions based on a careful assessment of risk.

Risk, a term that usually tends to invoke shudders because it is all about the “possibility that something can go wrong” is now omnipresent in quality management.  Risk based approaches to oversight, monitoring, inspections and more are the new normal.

There is a lot of frenzy around understanding the guidelines.  There are a lot of processes being put in place to make sure that ICH E6 (R2) is kept at the forefront of the way clinical trial processes evolve.  My question is this.  How are organizations getting their teams to change their mindset?  As far as I can remember, the words quality and compliance were at the heart of decisions.  How does one get employees to talk about and manage risk?

Since the launch of our Avoca Quality Consortium (AQC) five years ago, we have been working with our Members to prepare for this changing environment through the raising of awareness, cross-industry dialogue and the development of proactive, tool based approaches to managing quality.  Our Members believe that the best way to approach this change is to get the conversations flowing, not just within companies, but across the clinical trial ecosystem.

At our recent AQC Member meeting with executives, we heard loud and clear that the industry is mobilizing resources to understand and respond to the new guidelines.  This is now on top of our initiatives for 2017 where we will help our Member companies to understand the implications of ICH E6 (R2), guide them with leading practices and develop tools to respond and stay ahead.

We’d love to hear your thoughts on where you are in your journey in this risk based world of quality management.

Until next time………

Lakshmi

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Lakshmi Sundar has spent two decades in the pharmaceutical industry, leading teams across sponsors and CROs in multiple functional areas to spark innovation, manage risk, and lead change with a sense of purpose and fun. At Avoca, Lakshmi partners with members of the Avoca Quality Consortium and industry innovators to deepen the dialogue on building a quality culture within and across organizations to mitigate risk, advance drug development, and bring treatments to patients in a more effective manner. 

The post ICH E6 (R2) is top of mind appeared first on Avoca, a WCG company.

I sit here pondering what innovation might look like in this space. Could we move to a world where the word “inspection” does not trigger anxiety and fear? In a world where the marriage of data and technology has given birth to amazing possibilities, what if companies decide to share their inspection readiness experiences on a common, “lessons learned” platform?  What if the analysis of this dataset revealed that rather than making a few tweaks, a complete redesign of this process that builds in proactive approaches and intelligent tools could shave significant amounts of time and cost from drug development?  Would companies jump on this opportunity or still want to continue to do “business as usual”.

At the AQC, our members are striving to move from a reactive state of “inspection readiness” to a world of “inspection preparedness” where teams are empowered to build quality and do things right proactively, so that inspections become part of the normal fabric and can be handled with minimal stress and anxiety.  Initiatives that are currently ongoing at our member companies include

• Having tools in place to collect historical inspection data and using the data to proactively prepare for future inspections
• Identifying commonly requested documents in each country, so that the company can be submission-ready
• Using systems to identify sites that have a higher probability of inspection and understanding why

I’d love to hear your thoughts on this.  Have you undertaken this type of analysis internally?  How has this helped you?  And more importantly, would you jump on this journey to sharing where collectively we can help all boats rise?

Until next time….

Lakshmi

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Lakshmi Sundar has spent two decades in the pharmaceutical industry, leading teams across sponsors and CROs in multiple functional areas to spark innovation, manage risk, and lead change with a sense of purpose and fun. At Avoca, Lakshmi partners with members of the Avoca Quality Consortium and industry innovators to deepen the dialogue on building a quality culture within and across organizations to mitigate risk, advance drug development, and bring treatments to patients in a more effective manner. 

The post Can we move to a world where the word “inspection” does not trigger anxiety? appeared first on Avoca, a WCG company.

Here at Avoca, we are a rather curious bunch and wanted to know a bit more about what topics around Brexit are top of mind for pharma decision makers.  So we analyzed over 8,500 words and created a word cloud using the top ten search results from Google news for ‘Brexit + Pharmaceutical Industry’.

To address some of the challenges surrounding Brexit, drug industry and government officials have set up a task force.  While no one can quite predict how this will turn out, we are weaving the topic of Brexit into our global work.  Questions that we will work through with our AQC Members include:

• How will guidelines be adjusted for approvals? 
• How will the world of inspections be handled post Brexit?
• For companies that have created unified approaches in the drug development space for Europe, will Brexit add an additional layer of regulation and bureaucracy?

We would love to hear about your reactions and thoughts in preparing for this transition.

Until next time…

Lakshmi

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Lakshmi Sundar has spent two decades in the pharmaceutical industry, leading teams across sponsors and CROs in multiple functional areas to spark innovation, manage risk, and lead change with a sense of purpose and fun. At Avoca, Lakshmi partners with members of the Avoca Quality Consortium and industry innovators to deepen the dialogue on building a quality culture within and across organizations to mitigate risk, advance drug development, and bring treatments to patients in a more effective manner. 

The post Brexit – Will it or won’t it change the way drug development is done in Europe? appeared first on Avoca, a WCG company.