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Dec 11, 2024

DRAP Guidelines on National Pharmacovigilance System: International Collaboration

The new article describes the basics of international collaboration, aimed at further improvement of the regulatory framework and establishing a more efficient information exchange in order to ensure the proper performance of healthcare products as well as the safety of patients.

Dec 11, 2024

DRAP

DRAP Guidelines on National Pharmacovigilance System: Indicators

The final article of the cycle provides additional details regarding specific indicators used in the context of a pharmacovigilance system.

Dec 11, 2024

DRAP

DRAP Guidelines on National Pharmacovigilance System: Types of Surveillance

The new article elaborates further on the existing types of surveillance, highlighting the key points associated thereto.

Dec 11, 2024

MDCG

MDCG Guidance on Qualification of In Vitro Diagnostic Medical Devices: Specific Product Categories

The final article of the cycle highlights the key points related to certain specific product categories, outlining the most important aspects to be taken into consideration.

Dec 11, 2024

MDCG

MDCG Guidance on Qualification of In Vitro Diagnostic Medical Devices: Accessories and Related Products

The new article provides an overview of the regulatory status of accessories and related products as set forth under the existing legal framework.

RegDesk Regulatory Roundup

DRAP Guidelines on National Pharmacovigilance System: International Collaboration

DRAP Guidelines on National Pharmacovigilance System: Indicators

DRAP Guidelines on National Pharmacovigilance System: Types of Surveillance

MDCG Guidance on Qualification of In Vitro Diagnostic Medical Devices: Specific Product Categories

MDCG Guidance on Qualification of In Vitro Diagnostic Medical Devices: Accessories and Related Products

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