Hello <<First Name>>,
Welcome to the BioPhorum newsletter. Each month we cover news and developments from across the industry.
In this issue…
Have you ever wondered how to implement Agile in a GxP environment? The IT Agile workstream has published a supplementary guide - Agile in GxP Environment: Companion document to provide practical advice on how to implement agile in the biopharmaceutical arena.
A recently released paper, ‘Recommendations for harmonizing local regulations for post-approval submissions’ demonstrates how months, or even years, can be shaved off the time needed to implement a post-approval change.
Finally, we look through a member’s eyes at the valuable insight generated by a new tool to support the use of balanced scorecards.
As always, we welcome your feedback - email communications@biophorum.com |
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The ‘how to’ guide to implementing Agile in GxP
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The publication of the Guidance on the use of Agile in a GxP Environment document in 2017 was well received.
It described how the use of Agile in a GxP environment was limited due to perceived regulatory risks. The Guidance provides an approach that ensures delivery of software solutions while at the same time maintaining regulatory compliance. It also details the approach and key prerequisites needed for Agile to be successful.
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Slicing years off change implementation
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Harmonizing post-approval change regulations
As the first regulatory authority in Latin America to gain full membership of the International Council for Harmonization (ICH), the Brazilian Health Regulatory Agency (Anvisa) asked BioPhorum to support it in its review of national regulations relating to post-approval change (PAC) submissions.Sciences and has already been viewed online more than 1,000 times.
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Perfecting balanced scorecards for CDMOs
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Establishing best practice guidance for outsourcing
Established in March 2017, the Development Group’s Development Outsourcing effort aims to share and build guidance that will help companies make the best decisions and understand what to do in the areas of make vs buy, supplier selection, supplier management and oversight, governance and risk management and how to be a good customer.
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New BioPhorum members this month
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BioMérieux will join the Technology Roadmapping Phorum. The company provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. BioMérieux’s products are mainly used for diagnosing infectious diseases and also for detecting microorganisms in pharmaceutical products.
Cell & Gene Therapy Phorum continues to expand with another new member this month, Sangamo Therapeutics. This company was the first to edit human cells, the first to conduct clinical trials with gene edited T cells and initiated the first ever in vivo genome clinical trials. Their expertise will be a valuable addition to this ever-growing Phorum.
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Particulate Control Meeting, Raleigh,
NC, 2-4 April – conclusion of standard methodology v2 and kick start next steps.
Testing, Validation, Quality, Release Standards,
New York, 3-5 April - finalization of risk assessment model and development of standard vendor validation package.
Disposables Supply Base Reliability,
Seattle, 9-11 April – authoring of version one of the leakage toolkit and operator bag handling materials.
Microbial Control,
Portsmouth, NH, 9-11 April – annual workstream meeting looking at deliverables for vision of contamination free processes.
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Cell & Gene Therapy Leaders’ Meeting,
Boston, MA, 25-26 April – third leadership meeting focusing on raw materials outsourcing and validation for C>.
Change Notification,
Oxford, UK,30 April – 2 May – ‘Disposables change notification Community of Practice’ kick off.
Isolator Good Operating Practice,
Pearl River, NY, 30 April – 2 May – to complete best practices guides, re-scope workstream and plan adoption.
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