News Archives - Health Sciences Records and Archive Association

MHRA GLP Stakeholder Engagement Meeting

Posted on September 1, 2022September 1, 2022 by Administrator

Each year the HSRAA is invited to represent the views of archivists at the MHRA GLP StEM (Stakeholder Engagement Meetings). The 2022 StEM will take place in September (date to be confirmed). With the HSRAA represented, this gives members (and...Read More

EMA Launches Pilot Project on Analysis of Raw Data from Clinical Trials

Posted on September 1, 2022September 1, 2022 by Administrator

Raw data in electronic structured format is currently not systematically included as part of marketing authorisation and variation applications submitted to EMA. However, the Regulations which govern the work carried out by EMA allow for request of raw data during...Read More

EMA Clinical Trials Highlights Newsletter No10

Posted on September 1, 2022September 1, 2022 by Administrator

The latest edition of the EMA Clinical Trials Information System (CTIS) Newsletter provides insights on clinical trials topics. Of particular interest to HSRAA members is that the Accelerating Clinical Trials (ACT) EU programme is organising a series of workshops on...Read More

Publication of EMA Big Data Steering Group Workplan

Posted on September 1, 2022September 1, 2022 by Administrator

The EMA Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. For more information, please see here.

Article: How to Validate Adobe Sign in a GxP Content

Posted on September 1, 2022September 1, 2022 by Administrator

The use of Adobe Sign for creating and managing GxP e-signatures is increasingly sought after by pharmaceutical and healthcare organisations. In this blog, Gianna de Rubertis of Montrium uncovers the advantages of Adobe Sign and how it can be used to...Read More

Article: Guide to eTMF and Clinical Data Archiving and Preservation

Posted on August 31, 2022August 31, 2022 by Administrator

Arkivum has revised and updated its interactive guide to eTMF and clinical data archiving and preservation. Not only is it packed full of expert insights, great tips and useful resources, but Arkivum has also added new sections and updated favourite topics, including: Why...Read More

HSRAA 2022 Conference Programme published

Posted on July 6, 2022July 6, 2022 by Neil Gow

The Programme for the 2022 Annual Conference of the Health Sciences Records & Archives Association (The HSRAA) is now available…… The Programme includes the choice of two workshops, followed by two days of presentations, round table discussions and a Think Tank panel...Read More

Speaker announcement for the 2022 Annual Conference of the Health Sciences Records & Archives Association

Posted on June 30, 2022June 30, 2022 by Neil Gow

The HSRAA is delighted to announce that Stan Konopka, VP Information Technology at Avacta, will be presenting at HSRAA22. In the session, Stan will be discussing a wide range technological opportunities and challenges related to security issues in the development and implementation...Read More

HSRAA to present a Pre-Conference Workshop at the Operationalize: Electronic Trial Master Files Summit

Posted on June 16, 2022June 16, 2022 by Neil Gow

We are delighted to announce that Jamie Toth & Hobson Lopes from the HSRAA will be presenting “Exploring Archiving Considerations & Challenges to Effectively Navigate Shifting Regulations” as a pre-conference workshop at the “Operationalize: Electronic Trial Master Files Summit -...Read More

HSRAA 2022 Conference dates announced

Posted on June 14, 2022July 6, 2022 by Neil Gow

The HSRAA is delighted to announce that the 2022 Annual Conference will take place from the 28-30th September at the Holiday Inn, Manchester City Centre. The format of the Conference will be similar to previous years. Pre-conference workshops will take place...Read More

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