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On Friday, 22 September 2017, a GCP/GPV training day was held with the subject: "Safety Information from a GCP Perspective".

The day started with a presentation on “Core concepts in pharmacovigilance auditing” by Marielle Keulen, Xendo. It was followed by presentations which covered different aspects of Safety information which included Reference Safety Information (RSI) from Clinical Trial and Post marketing perspectives, presented by Deepti Naik, PRA Health Sciences and Marielle Keulen.

Pharmacovigilance aspects which one comes across during day to day GCP or during monitoring was presented by Deepti Naik in her presentation “Safety information at investigator sites” hereby linking GCP and GPV. Final presentation for the day was on “Reference Safety Information from a QA perspective” presented by Laurentiu Chitimia, Astellas. The day concluded with a Q&A session with the speakers of the day.

Points of discussion were:

  • RSI- its importance and criticality
  • Changes to the regulations with regards to RSI
  • Commonly observed issues and audit findings related to RSI

Around 35 participants from different backgrounds including QA, Pharmacovigilance Operations attended the training day. The cross functionality of the topic linking GCP and GVP and the wide range of the audience backgrounds lead to lively discussions and a very interactive training day.

The presentations of this day are now available for download for our members. Sign in first and go to https://www.darqa.org/downloads/category/46-2017

The non-DARQA members who were present can send an email to the Dit e-mailadres wordt beveiligd tegen spambots. JavaScript dient ingeschakeld te zijn om het te bekijken. for sending the presentations.

 

 

ECCRT en Biotech Training Facility bundelen hun krachten voor het geven van trainingen

Beide werelden van Good Clinical Practice (GCP) en Good Manufacturing Practice (GMP) komen samen in het partnerschap tussen de ervaren European Centre for Clinical Research Training (ECCRT) in Brussel in Belgie en Biotech Training Facility, de unieke hands-on GMP trainingsorganisatie in Leiden in Nederland.

Sinds juli dit jaar hebben beide organisatie de handen ineen geslagen. Met dit partnerschap zijn ze in staat om een grote verscheidenheid aan trainingen te geven in deze complementaire gebieden. Denk hierbij bijvoorbeeld aan Clinical Research Training voor Junior en Senior CRA’s gegeven door ECCRT en mid-level GMP training voor QA personeel en operators gegeven door Biotech Training Facility. En deze trainingen zijn niet alleen gepland in Brussel en Leiden, maar kunnen ook gegeven worden in Londen, Rome, Milaan en München.

Met ervaren trainers bieden beide organisaties naast open trainingen ook op maat trainingen aan voor hun klanten. Ook kunnen consultants van beide organisaties hun expertise toepassen om klanten te helpen bij problemen en vraagstukken.

Voor meer informatie kunt u terecht op de websites van beide organisaties www.biotechtrainingfacility.nl en www.eccrt.com.

 

ICT in het GXP-domein

Locatie: Regardz De Eenhoorn, Amersfoort.

  1. Opening

Hans de Raad, voorzitter ICT commissie, opent als dagvoorzitter deze themadag “ICT in het GXP-domein”. Er zal vanuit ICT, GCP, GLP en GMP worden belicht hoe ICT van invloed is op in het GXP-domein.

De presentaties van alle sprekers staan op downloads/Events 2017 (wel eerst inloggen).

 

GLP Guidance documents

An Advisory Document on Test Itemsis being developed by a drafting group, originally under the leadershipof Canada, and now by the United Kingdom, Denmark (Pharmaceuticals) and Italy. The objective of the document is to consolidate text in existing guidance documents that refer to “test item”, as well as promote a consistent approach for performing characterisation of test items. The first draft of the Document was reviewed at the 28th Working Group meeting in April 2014. After subsequent iterations, the latest draft will be reviewed by the March 2017 meeting of the Working Group. It is anticipated that a revised version will be posted on the OECD’s website for public comment in Q2 of 2017.

The United Kingdom and Japan (Medical Products) are leading efforts to develop version three of a public web page concerning Frequently Asked Questions (FAQ) raised by testing laboratories about implementation of GLP, along with responses prepared by the Working Group. (Versions one and two of the FAQ are posted on the public site.)
Version three of the FAQ will include three topics related to whether software programmes developed by outside vendors to support calculations by test facilities using OECD Test Guidelines need to be validated by such facilities, and clarification regarding two issues raised after the publication of the OECD’s Guidance Document No. 16 on the GLP Requirements for Peer Review of Histopathology. The last two issues concern: the retention of correspondence during a peer review of histopathology, and differences of interpretation between a reviewing pathologist and the original interpretation of the study pathologist. The Working Group is reviewing the final draft, and publication is anticipated by Q1 or Q2 2017.
 

DARQA Logo Regulatory Focus GroupDe DARQA Regulatory Focus Group heeft tot doel het becommentariëren en reviewen van nieuwe regelgeving, concept-guidelines en richtlijnen in revisie.

DARQA leden die betrokken willen worden bij de evaluatie en becommentariëring van nieuwe of gewijzigde wet- en regelgeving kunnen zich HIER aanmelden voor de Regulatory Focus Group op LinkedIN.

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