Data integrity in regulated bioanalysis: a summary from the European Bioanalysis Forum Workshop in collaboration with the MHRA

In this conference report, we summarize the main findings and messages from a workshop on ‘Data Integrity’. The workshop was held at the 11th European Bioanalysis Forum Open (EBF) Symposium in Barcelona (21–23 November 2018), in collaboration with the Medicines and Health products Regulatory Agency to provide insight and understanding of regulatory data integrity expectations. The workshop highlighted the importance of engaging with software developers to address the gap between industry’s data integrity needs and current system software capabilities. Delegates were also made aware of the importance of implementing additional procedural controls to mitigate the risk associated with using systems that do not fully meet data integrity requirements.

Download Full-text

Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.1794 ◽

2020 ◽

Vol 108 (5) ◽

pp. 949-963

Author(s):

Ni A. Khin ◽

Gail Francis ◽

Jean Mulinde ◽

Cheryl Grandinetti ◽

Rachel Skeete ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Drug Administration ◽

Regulatory Agency ◽

Food And Drug Administration ◽

Data Integrity ◽

Good Clinical Practice

Download Full-text

Improving data integrity in regulated bioanalysis: proposal for a generic data transfer process for LC–MS from the European Bioanalysis Forum

Bioanalysis ◽

10.4155/bio-2020-0156 ◽

2020 ◽

Vol 12 (14) ◽

pp. 1033-1038

Author(s):

Cecilia Arfvidsson ◽

David Van Bedaf ◽

Susanne Globig ◽

Magnus Knutsson ◽

Mark Lewis ◽

...

Keyword(s):

Information Management ◽

Transfer Process ◽

Data Transfer ◽

Data Integrity ◽

Management Systems ◽

Software Developers ◽

Generic Data ◽

Information Management Systems ◽

Minimum Dataset

In this paper, the European Bioanalysis Forum reports back from the discussions with software developers, involved in regulated bioanalysis software solutions, on agreeing to data transfer specification in the bioanalytical labs’ LC–MS workflows as part of today’s Data Integrity (DI) challenges. The proposed specifications aim at identifying what consists of a minimum dataset, that is, which are the pre-identified fields to be included in DI proof bidirectional data transfer between LC–MS and information management systems. The proposal is an attempt from the European Bioanalysis Forum to facilitate new software solutions becoming available to increase compliance related to DI in today’s LC–MS workflows. The proposal may also serve as a template and inspiration for new data transfer solutions in other workflows.

Download Full-text

Treatment of the novel COVID-19: why Costa Rica’s proposal for the creation of a global pooling mechanism deserves serious consideration?

Journal of Law and the Biosciences ◽

10.1093/jlb/lsaa049 ◽

2020 ◽

Vol 7 (1) ◽

Author(s):

Muhammad Zaheer Abbas

Keyword(s):

Point Of Care ◽

World Health ◽

Director General ◽

Point Of Care Diagnostics ◽

Travel Restrictions ◽

Regulatory Data ◽

Health Products ◽

The Creation ◽

Health Organization ◽

Spread Of Infection

ABSTRACT The COVID-19 is causing not only deaths and fear but also economic and social harm across the globe. Lockdowns, travel restrictions, quarantines, social distancing, and other strict public health measures are playing their part in delaying the spread of infection, but a safe and potent vaccine, effective therapeutics, point-of-care diagnostics, and other health products are desperately needed because it may not be practically possible for governments to extend these measures for an indefinite period of time. On March 23, Costa Rica submitted a proposal to the Director-General of the World Health Organization for the creation of a global pooling mechanism in order to facilitate access to and use of intellectual property, trade-secret know-how, regulatory data, cell lines, product blueprints, and other proprietary data for technologies that are useful for the detection, prevention, control, and treatment of the COVID-19 pandemic. This study critically evaluates Costa Rica’s proposal and endeavors to briefly answer the following questions: Why Costa Rica’s proposal deserves serious consideration? To what extent this proposal addresses some of the key concerns related to the COVID-19? To what extent this proposal is practically feasible?

Download Full-text