Agenda van de ACRON

“Science, Technology and Regulations Coming Together for Better Patients’ Health”.

Please join us for a two-day conference with scientific sessions and open forum panel discussions and highly qualified expert speakers from the EMA and further Regulatory Agencies as well as from (Bio)Pharmaceutical and patient organisations who are uniquely placed to debate and highlight the key themes: developments, trends and current practices.

Some of the highlights will be:

• Patient Centric Approaches – the importance of engaged research patients,
• Fulfilling recently revised GCP Requirements on Oversight and Quality Management System,
• New guidance on Optimisation of Safety Data Collection (E19),
• Solutions to address Challenges with eTools,
• Harnessing as much Value as possible from your Research Data,
• Understanding the Impact of GDPR on Clinical Research.

The year 2020 is also an important year for EUCROF and its members. We will celebrate the 15th Anniversary of EUCROF, the 25th Anniversary of ACRON, the Dutch CRO Association, and the 10th Anniversary of BeCRO, the Belgian CRO Association. You are all kindly invited to join the celebrations at the special Heineken event.

More information about the conference is available here.

Early Bird registration closes on 30th November 2019!

Register: link to be used - https://eucrof-conference.eu/registration/

Event website: link to be used - https://eucrof-conference.eu/

Attendance Fee:
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members

Overview

Patient centricity has become something of a buzz phrase over the last few years. However, behind the name, a concept that offers real value can be found. Such benefits will be discussed during this webinar, highlighting:

1. Results from recent research that quantifies the positive business impact to sponsors by taking a patient centric approach;
2. Exploration of real examples where the patient has benefited from being put at the heart of clinical research;
3. Advantages experienced by sites when patients are central to study planning and implementation

This informative session will provide you with data and examples you can bring back to your own organization, in order to support the development and growth of patient centric practices. Furthermore, a collaborative discussion about the future of patient centricity and its effects on the industry will complete the webinar.

Moreover, the webinar will provide practical examples on how to involve children in clinical trials.
A child-friendly approach is necessary not only in the daily clinical practice, but throughout the research and development process, from setting research priorities, involvement in research design and planning, research conduct to dissemination and communicating research findings. In case of studies involving children, age-tailored information booklets, assent forms and summaries of the results should be written in age-appropriate, simple and understandable language to ensure ease reading by parents and children. Moreover, the investigators should obtain agreement from the child in addition to informed consent of his/her parents, even when such an agreement is not mandatory by law.
An innovative approach for the patients’ involvement in paediatric clinical research is represented by the Young Persons Advisory Groups, an organization composed of youths, patients and carers actively participating in clinical research and advising researchers and their teams.

Presenters:

Rosamund Round
Vice President, Patient Innovation Center
Parexel International

Mariangela Lupo
Patients Advocacy Manager
TEDDY European Network of Excellence for Paediatric Clinical Research
Head of the Training and Advocacy Area
Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)

See full biographies on our website

Registration

>> How to register?
1) Go to our Eventbrite page
2) Click on the green "REGISTER" button
3) Check your order and click on the green "CHECKOUT" button
4) Fill in all the necessary information and validate your order

>> Confirmation
You will receive 2 confirmation emails :
A) One from Eventbrite with your invoice
B) One from Assia Rosati, sent by GoToWebinar, our webinar platform, with all the necessary information to connect on the D-Day!

Informatie over het programma, de verschillende subsessies en de wijze van inschrijven volgen in februari. Houd hiervoor de website van ZonMw in de gaten.
Ook kunt u zich abonneren op de nieuwsbrief Geneesmiddelen; hierin leest u actuele informatie rondom het GGG-congres.

Het GGG-congres 2020 richt zich op resultaten uit onderzoek vanuit het GGG-programma, lopende projecten binnen verschillende aandoeningen en groepen geneesmiddelen en sluit aan op actuele ontwikkelingen. Een eerste tip van de sluier: er staan interessante subsessies over onder andere psychedelica als medicijn, hart- en vaatziekten, diabetes, personalised medicine, therapietrouw en patiëntenregistraties op het programma. En voor de eerste lijn zijn er gerichte sessies over biologicals, farmacogenetica, geneesmiddeleninformatie en de duurzame huisarts. Ook is er een interactieve ronde waarin uiteenlopende onderwerpen aan de orde komen.
Genoeg reden dus om dit congres alvast in de agenda te zetten!

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OPROEP 1

Voor een sessie over bijvangst tijdens het congres Goed Gebruik Geneesmiddelen op 9 april zijn we op zoek naar GGG-projecten met onverwachte bijvangst.

Bent u die onderzoeker die een project gefinancierd kreeg door het GGG-programma en gedurende het onderzoek iets op het spoor bent gekomen wat een extra onverwachte opbrengst opleverde? Of heeft uw onderzoek veel meer teweeggebracht naast de beoogde doelstellingen? Heeft uw project inzichten gegeven of resultaten opgeleverd - los van het primaire doel van uw project - die van belang kunnen zijn voor anderen? En wilt u deze tijdens het congres presenteren? Vul dan het formulier in met informatie over deze bijvangst. Uit de reacties maken we een keuze voor de invulling van de sessie over bijvangst. Deadline: 1 februari 2020.

Aanmelden bijvangst

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OPROEP 2

Heeft u momenteel een probleem met de beschikbaarheid van geneesmiddelen voor zeldzame aandoeningen? Is er een dreigend probleem met een geneesmiddel voor een zeldzame aandoening? Of heeft u vragen over hoe u zelf een (nieuwe) behandeling optimaal beschikbaar kunt maken voor een zeldzame aandoening?

Meld uw casus hier aan of stel een vraag. Tijdens de interactieve sessie ‘Medicijn voor de Maatschappij’ kijken we of en hoe we kunnen helpen. Deadline: 5 maart 2020.

Meld uw casus aan of stel een vraag

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Samenwerking
Ook dit jaar wordt samengewerkt met Instituut Verantwoord Medicijngebruik (IVM), College ter Beoordeling Geneesmiddelen (CBG), Bijwerkingencentrum Lareb, Zorginstituut Nederland (ZIN) en Geneesmiddelenbulletin (GEBU) en ondersteund door het Nederlands Huisartsengenootschap (NHG).

Kijk voor meer informatie/inspiratie: Impressie GGG-congres 2019

Met vriendelijke groet,

het GGG-team

Bij deze nodigen wij u van harte uit voor de Voorjaarsvergadering van de ACRON, die zal plaatsvinden op dinsdag 9 juni 2020. Vanwege de coronamaatregelen is deze vergadering omgezet naar een Teams(online)vergadering.

Mocht je willen deelnemen, stuur dan een mail naar info@acron.nl en wij sturen je de inbelgegevens en bijbehorende stukken toe.

Dear Colleagues,

As Chair of the Events & Training Working Group, I am pleased to announce our next webinar.

Next Webinar Topic: Electronic Informed Consent … a global perspective

Date & Time: 30 June 2020 from 10:00 AM to 11:30 AM (CEST)

Attendees: Project Managers, Regulators, Archivists, Monitors, Quality Assurance and any other person involved in Clinical Trials

Attendance Fee:
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members (promotiecode op te vragen bij het ACRON secretariaat)

Next Webinar Topic: COVID-19 in the Paediatric Population

Date & Time: 24 July 2020 from 10:00 AM to 11:30 AM (CEST)

Attendees: Paediatricians, Medical Directors, Qualified Persons, Healthcare Professionals, Patients Advocates and Associations

Overview
The presentation covers epidemiology, infectivity and incubation period, mode of transmission, clinical presentation, prevention, socio-ecological impact, frequently asked questions, and clinical trials with COVID-19 together with the risk management.

Attendance Fee:
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members

More information: https://www.eventbrite.com/e/covid-19-in-the-paediatric-population-registration-112089948052

EUCROF Members are entitled to participate at a reduced fee: in the invite below, the EUCROF promocode can be obtained at the ACRON secretariat (info@acron.nl) When registering to the event on the EUCROF website, you just need to insert the code to pay the reduced amount.

This message is not for non-EUCROF Members, who might just wish to go to the EUCROF website and register to the Webinar section (www.eucrof.eu/webinars).

Summary:

Software is used widely in clinical trials: from managing worldwide trials to finding and scheduling patients, gathering trial data, and analyzing trial results. How is the quality of the computerized systems ensured? And how do we know the data generated by these systems is reliable and robust?

Validation of software ensures that clinical data generated by these systems is done in a structured way and ensures integrity, reliability, and robustness of the generated data.

In this 1-hour webinar, you will learn why computerized systems must go through a validation process when used in clinical trials, as well as the consequences of failing to validate your systems. We will explain the requirements for validation, who is responsible and when it is necessary. Through the speaker’s experience, you will learn the why, what, and how of validation with regards to regulatory requirements.

This webinar also provides you with a walk through the process of system validation and its key deliverables. And finally, you will be shown the way to either manage the validation process of your own system or make the right considerations when selecting software for your clinical trials.

Webinar takeaways for the audience
1. Understand for which software validation is required and in which regulations requirements for validation are documented
2. Understand who is responsible for validation and what the goal of validation is
3. Know what to look for when choosing software to be used in your clinical trial
4. Understand what steps should be taken to validate your (vendors’) system
5. Be aware of the challenges in the validation process and know how to ensure a smooth process

Presenter: Marieke Meulemans

Overview
This webinar provides a demonstration of the current status of the Clinical Trials Information System (CTIS) which is currently under development, combining presentations and discussions
on the underlying principles and concepts with demonstrations of specific functionalities.

After a brief introduction and overview of CTIS, the workspace functionalities that are specifically designed for use by clinical trial sponsors, including commercial and noncommercial (academic) sponsors will be demonstrated.
Following, the user roles, their hierarchy, and related permissions as well as access policies of users will be presented and how to manage these in the system.
Functionalities for creating and managing a clinical trial application in CTIS will be outlined, and some practical advice as to how the system will be able to support users to manage their daily work and workload planning will be shared.
Presentations will be provided by system experts complemented by pre-recorded demonstrations of the system, and rounded up in a live Q&A.

Key Topics
Brief introduction to the Clinical Trials Information System (CTIS)
Access management
Sponsor user management – principles and concepts
Role matrix - principles, concepts and sponsor roles
CTIS Sponsor workspace
General overview
Sponsor user administration in CTIS
Clinical Trial Application management step by step
Tools for user workload overview and management
Preparations for CTIS Go-Live
Current status and future master trainer involvement

Who Should Attend
Clinical trial sponsor staff representing commercial sponsors such as pharmaceutical companies
and CROs, SMEs, non-commercial sponsors including academia, research institutions. CTIS
Stakeholder associations representatives. Expert trainers with an interest in the area of Clinical
Trials

More information can be found at the EMA website

A webinar to consider the  impact of the pandemic on data collection and data management – guidelines and practical advice

- How the pandemic has affected data collection in clinical trials and other studies.

- Current EMA and FDA guidance on data collection in studies affected by COVID-19.

- What does all this mean for my study?

- Considerations for patient collected data.

- Practical considerations for implementing the guidance to overcome the current challenges.

- Data collection perspectives for future studies.

- The emerging trend of virtual studies, digital technologies, and telemedicine to mitigate future risks to data collection in clinical research

Rate: £75 + VAT

Click here to order online

Deze bijeenkomst is definitief afgelast

Register now for the RSNN virtual workshopRegistration for the virtual RSNN workshop organized together with EMA on 17 November 2020: "Leveraging the value of collaboration - from regulatory science to regulatory innovation" is now open.Online event broadcasted from Villa Jongerius in Utrecht (Zoom meeting)Date: Tuesday 17 November 2020, 13:30 - 17:30

Registration: Free of charge

Target audience: Experts from EMA, academia, (bio)pharmaceutical industry, patient communities, regulatory authorities and the medical professionThis year’s workshop will be chaired by Sabine Straus (CBG-MEB). In this RSNN workshop we explore the key regulatory science questions in the coming years, and especially address how collaborative research can be of most value for regulators, patients, companies, HTA bodies, academia and other stakeholders. Discussions with the audience, representing various backgrounds are a critical element in this respect.In the first part of the workshop, experts will share their point of view on the main theme, including among others Tony Humpreys (European Medicines Agency), Marjon Pasmooij (CBG-MEB) and Jarno Hoekman (Utrecht University). In the second part, 10-minute presentations will be given by a number of speakers on recent regulatory science case studies, with special attention to key success factors. The workshop will close with a discussion session and final remarks from Tony Humpreys. On behalf of the program committee,RSNN secretariat in collaboration with our media partner Vital Transformation.

More information

Register now