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Responsibilities of MAHs participating in work-sharing initiatives for additional risk minimisation measures

Posted by: , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice
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...access programmes, pregnancy prevention programmes and direct healthcare professional communication (DHPC). Risk management is an evolving field and the design, implementation and evaluation of risk minimisation measures should be proportionate,...

MHRA’s GXP data integrity guide published

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...as illustrated by the receipt of over 1300 comments from industry, and trade and professional groups across all GXPs during the consultation process. Such a high degree of engagement required...

The Responsible Person named on the WDA- Part 3: Expectations for the engagement of consultants as contract RPs

Posted by: and , Posted on: - Categories: Compliance matters, Good distribution practice
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...a suitable training record available to the licence holder and inspector. They must put time aside for their own learning, regulatory awareness updates and professional development in addition to their...

Falsified Medicines Directive: Safety Features

a photograph showing the safety features applied to pharmaceutical packaging consisting of a 2D barcode with human readable data and a tamper evident seal

...Gov.uk, including the following: Guidance for Wholesalers Guidance for parallel import license holders Homecare Additional guidance on Article 23 providers, Healthcare Institutions and Article 26 exemption RPS professional guidance for...

Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice

...following elements of their control strategy that they should ensure they are addressing: Health Based Exposure Limits (HBELs) completed for all products by experienced professional Toxicologists So what is going...