EFGCP Better Medicines for Children Pre-Conference Workshop

Datum: 17 October 2022
Tijd: 00:00 - 00:00
Locatie: Virtueel

In Spring 2022, the International Council for Harmonization (ICH) published the E11A draft guideline establishing a framework for extrapolation from existing data to the pediatric population. The new guideline aims to promote international harmonization of methodologies and strategies to incorporate pediatric extrapolation into overall drug development plans, improving the speed of access to new drugs for pediatric patients while limiting the number of children required for enrolment in clinical trials. The extrapolation framework consists of a pediatric extrapolation concept, and the creation and execution of an extrapolation plan. This workshop has been designed to provide pediatric researchers, trial sponsors, and regulatory reviewers an opportunity to actively engage with experts to learn the fundamentals of developing a pediatric extrapolation concept and plan.

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EFGCP Better Medicines for Children Conference 2022

Startdatum: 18 October 2022
Einddatum: 19 October 2022
Tijd: 00:00 - 00:00
Locatie: Virtueel

The EFGCP “Better Medicines for Children” Conference is an annual flagship event providing a unique opportunity to share best practice, reflect on what has happened since we last met in October 2021, and discuss paediatric updates with a truly global outreach. The conference will focus on Global Paediatric Development, its challenges and solutions, and in particular on what has been achieved during the pandemic, and the remaining opportunities and challenges. To this effect, the conference brings together not only distinguished speakers from all around the world but also all the stakeholders involved in paediatric drug development.

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EFGCP: Implementing “Good Lay Summary Practice”

Startdatum: 14 February 2022
Einddatum: 21 February 2022
Tijd: 00:00 - 00:00
Locatie: Virtueel

The “Roadmap Initiative to Good Lay Summary Practice” aims to develop a pragmatic, broadly accepted framework for LS planning, development, translation and dissemination.
In this virtual 3 afternoons Workshop the key content of GLSP will be presented and hopes and hurdles for its implementation raised on Day 1. On Day 2 participants will be able to join 2 out of 4 Break-out Sessions of their choice in which concrete proposals will be worked out on how best to prepare our communities for the respective particularly challenging aspects of GLSP. On Day 3 the results from these Break-out Sessions will be presented, jointly discussed and conclusions proposed to inspire the European Commission’s and the Roadmap’s second important objective: the implementation of GLSP in clinical research daily practice including training opportunities for all involved stakeholders.

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EFPIA & EFGCP “Good Lay Summary Practice” Recommendations

Datum: 9 November 2021
Tijd: 00:00 - 00:00
Locatie: Webinar

A multistakeholder group consisting of 60+ academic, industry, not-for-profit and patient organisations, jointly led by EFGCP and EFPIA, (“Roadmap Initiative for Good Lay Summary Practice”), compiled needs for transparency improvement on clinical study results, available guidance and experience when preparing and disseminating Lay Summaries (LS) in Europe and the US. Based on existing recommendations for Lay Summary structure and content, recommendations for the planning, development, translation, and dissemination of LS with systematic patient involvement were developed in collaboration with the Commission’s Expert Group on Clinical Trials (CTEG) and published by the EU Commission in EudraLex Volume 10. This free webinar will give you an opportunity to learn about these new European recommendations and provide you with ideas on how and when to be ready to fulfil this new regulatory requirement.

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EFGCP: Certifying 2 Days Training – Principles of Clinical Quality Assurance Audits

Startdatum: 9 November 2021
Einddatum: 10 November 2021
Tijd: 00:00 - 00:00
Locatie: Online

This introduction to the Principles of Clinical Quality Assurance Auditing has been developed to cover the principles of GCP and how they can be applied to clinical trial audits in consideration of both computerised system and data integrity considerations. This interactive on-line workshop is developed and hosted by three experienced leading quality professionals, with broad experience of clinical trials in Europe, the UK and USA. It is recommended for delegates who are new to QA or wishing to move into auditing (1 to 3 years’ experience for example). With a primary focus on European and UK requirements over two days delegates will be given the opportunity to understand GCP legislation and how it can be applied to individual audits and audit programmes using a risk-based approach. The course includes both points to consider for face-to-face audits and those conducted remotely. As few clinical trials are successfully completed today without the use of electronic data capture systems and data collection tools, the workshop includes an introduction to computerised system validation and points to consider during routine clinical trials audits, as well as an overview of data integrity and application of the MHRA GXP Data Integrity Guidance.

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EFGCP Annual Conference 2021 ‘Clinical Research Value and Transparency’

Startdatum: 13 December 2021
Einddatum: 17 December 2021
Tijd: 00:00 - 00:00
Locatie: Virtueel

Clinical Research Value and Transparency - How to capitalise on the post-pandemic opportunities? 2020 and 2021 have changed the public’s and researchers’ attitude on value of clinical research and its transparency. Both used to be a ”Nice to have” and subject to good intentions but our experiences during the COVID-19 pandemic showed us the fundamental need for and benefits of clinical research excellence and reliable transparency for understanding the situation, making decisions and handling our way of living. And we have experienced a quantum leap in public interest in clinical research, biomedical research topics, methodologies and results. The EFGCP Annual Conference 2021 will provide the platform for multi-stakeholder discussions of the changes we are currently facing and for jointly finding more efficient ways to better fulfil the clinical research and transparency needs of patients and the public in the development of new prophylactic and treatments options from finding recruiting trials to reporting of results.

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