Agenda van de ACRON

De ACRON is de branchevereniging van CRO’s in Nederland. Wij behartigen de collectieve belangen van de aangesloten bedrijven (leden). Dit doen we door middel van het organiseren van bijeenkomsten, zowel besloten als open, netwerk en lobby activiteiten met als voornaamste doel om Nederland als onderzoeksland optimaal te laten functioneren. Bekijk hieronder de agenda van evenementen van de ACRON en Contract Research Organisaties (CRO’s) in Nederland:

  • di
    25
    jan
    2022
    12:00 - 13:00 uurVia Teams

    Beste leden,

    Sinds 1 november is de VGO als onderdeel van de lokale haalbaarheid procedure definitief geïmplementeerd. De ACRON wil je graag uitnodigen voor een online meeting waarin we nogmaals stilstaan bij dit document met een aantal leden van de DCRF-werkgroep lokale uitvoerbaarheid. Tijdens deze meeting willen we graag nog een korte uitleg geven, maar vooral tijd nemen om vragen te beantwoorden of ervaringen uit te wisselen. Daarom nodigen wij je graag uit voor deze online lunchmeeting op 25 januari van 12.00 tot 13.00 uur.

    Om te zorgen voor een dynamische meeting willen we je vragen om voorafgaand aan de meeting alvast vragen of onduidelijkheden met betrekking tot de VGO aan te leveren voor 18 januari 2022. Je kunt de vragen sturen naar info@acron.nl. Natuurlijk zal er ook ruimte zijn om tijdens de meeting vragen te stellen, maar we willen graag zo veel mogelijk vragen vooraf ontvangen om één en ander uit te werken in een presentatie.

    Mocht je de uitnodiging niet via mail of outlook hebben ontvangen en je wil graag deelnemen, stuur dan een mail naar info@acron.nl, dan sturen we je de deelnemerslink toe.

    Met vriendelijke groet,
    ACRON

  • ma
    07
    feb
    2022
    di
    08
    feb
    2022
    Madrid, Spain

     

     

    EUCROF invites you to the 6th Conference on Clinical Research
    February 7-8, 2022, Madrid, Spain 🇪🇸

    More information:

    6th European Conference on Clinical Research - EUCROF 2022 (eucrof-conference.eu)

    6th-ecocr-conference-programme-2021-11-05

  • vr
    13
    mei
    2022
    16:00 - 17:45Webinar

    2023 – When the CTR will be in force for all – Let’s be prepared

    Deze afbeelding heeft een leeg alt-attribuut; de bestandsnaam is eufemed-webinar-1.jpg1_-1-1024x1024.jpg

    The EU Clinical Trial Regulation has come into force on 31 January 2022. Although primarily aiming at making the EU a more attractive place for clinical research by facilitating and speeding up the approval process in multi-national trials, many national changes to authorisation and supervision of mono-national clinical trials are now applicable. The CTA application process including the structure of the CTA dossier is now identical in all EU and EEA countries. But the Regulation leaves it up to the Member States to organize the joint dossier assessment by competent authorities and ethics committees. How is this now working in practice in different countries? What is the impact on the review?

    Register here

    PROGRAM:

    Moderator: Izaak den Daas, QPS, The Netherlands

    16:00 - Welcome and Introduction

    16:10 - An overview of changing aspects for national Phase 1 trials under the EU Clinical Trial Regulation + Q&A - Ingrid Klingmann, Pharmaplex BV, Belgium

    16:35 - How are EU Member States organizing collaboration between competent authority and ethics committee in the trial authorization process? + Q&A - Round Table discussion incl. F, D, BE, NL, PL

    17:25 - General discussion

    17:45 - Closing remarks

    This is the first of four 2022 EUFEMED webinars. The next two webinars will also address relevant topics in relation to the Clinical Trial Regulation and the last one, in Q4, will invite to learn about a highly innovative clinical pharmacology topic. Register for all four and pay only for three webinars.

    Attendance fees (excl. VAT):

    • Member of a EUFEMED organisation:  € 30.00
    • Non-member: € 60.00
    • Member of a EUFEMED organisation(4 webinars): € 90.00
    • Non-member (4 webinars) : € 180.00

    Recognised EUFEMED member organisations include: Healixia (formerly the Belgian Association for Phase-I Units; BAPU, Belgium), Association Française de Pharmacologie Translationnelle (formerly Club Phase I, France), the Association for Applied Human Pharmacology (AGAH, Germany) and the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI, United Kingdom).

  • vr
    16
    sep
    2022
    16:00 - 17:30Webinar

     

    2nd EUFEMEDs INNOVATION CLUB WEBINAR
    16 September 2022, 16:00-17:30 CET
    Submitting an application for a CTA and what do sponsors from outside the EU need to consider?

    Your registration is still welcome and possible

    EUFEMED’s Innovation Club is inviting you to the second Webinar on preparation for the new regulatory environment under the Clinical Trial Regulation

    Under the Clinical Trial Regulation the clinical trial authorisation application has to occur in a new process: a “Single Dossier” has to be submitted to the “Single Portal” of CTIS (EU Clinical Trial Information System). Sponsors have to respond within a few days to deficiencies in the validation process and to “Requests for Further Information”. Access to CTIS, the dossier preparation and submission, and the decision making process on further information to be submitted require a very detailed planning and agreement between sponsor and clinical trial unit/CRO on responsibilities and oversight. In this webinar we will discuss strategies and first experiences on efficient collaboration between international sponsor organisati-ons and early phase service providers.

    Moderator: Izaak de Daas, QPS, The Netherlands

    PROGRAM:

    16:00  Welcome and Introduction
    16:05  Regeneron’s EU Clinical Trial Regulation implementation experience and insights + Q&A - Seán Kilbride, Magaly Woolard, Rishi Sarna; Regeneron
    16:45  Panel and Open Forum Discussion

    Moderator: Izaak den Daas, QPS
    Panellists: Magaly Woolard (Regeneron, UK), Sean Kilbride (Regeneron, UK),
    Nina Berberich (Morphosys, DE), Anne Jacquet (Eurofins Optimed, FR),
    Cynthia Lesbros (Eurofins Optimed, FR), Mariska Beukers (QPS, NL)

    17:25 Closing remarks
    17:30 End of the Webinar

    FEES (excl. VAT):

    Member ticket:         € 30.00
    Non-member ticket:  € 60.00

    Member tickets are available for members of: Association of Human Pharmacology in the Pharmaceutical Industry (AHPPI - UK), Healixia (Belgium), Association Française de Pharmacologie Translationnelle (AFPT – France), Association for Applied Human Pharmacology (AGAH - Germany), Associatie van Contract Research Organisaties in Nederland (ACRON - Netherlands)

    REGISTER NOW

    This is the second of four 2022 EUFEMED webinars. If you have already registered for all four webinars, you do not have to register again. Save the date for the next two events:

    4 November 2022 (16:00 - 17:30 CET): Reporting obligations under the
    Clinical trial Regulation: SUSARS, Serious Breaches, Summary of Trial
    Results and Lay Summary of trial results via CTIS

    9 December 2022 (16:00 - 17:30 CET): Christmas Lecture: Latest
    innovations in early medicines development

    ABOUT EUFEMED

    The European Federation for Exploratory Medicines Development (EUFEMED) was founded in 2015 as a result of an ongoing, informal collaboration between several European societies active in the area of human pharmacology.

    EUFEMED is a not-for-profit association established under the Belgian law. The mission statement of the federation addresses the development, protection and promotion of the interests of early clinical medicines research and development in Europe.

    Read more at: www.eufemed.eu

  • di
    01
    nov
    2022
    10:30 - 12:00Anatomiegebouw te Utrecht
  • di
    01
    nov
    2022
Contact

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