News Archive

APIC - Data Integrity FAQs

19th April 2023

A collection of frequently asked questions that have been submitted by the industry to the DI taskforce.

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EMA - Interview with Peter Arlett

19th April 2023

LinkedIn Live interview with Peter Arlett: Real-world evidence in medicines regulation, 20 April at 14:00-14:30 CET

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EMA - Human Medicines Highlights Issue April 2023

12th April 2023

Issue 168

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023

12th April 2023

View the meeting highlights.

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EMA - New features further strengthen PRIority Medicines scheme (PRIME)

12th April 2023

EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of unmet medical needs.

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MHRA Blog - Happy 75th Anniversary to the World Health Organization

12th April 2023

On 6th April 1948, the United Nations (UN) came together to establish a global organisation that promotes health, keeps the world safe, and serves the vulnerable. Seven decades later, the World Health Organization (WHO) is celebrating its 75th anniversary.

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ECA - New Guide on GMP Compliant Equipment Design

5th April 2023

The purpose of this Guide is to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made.

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ICH - Q9 QRM Revision reaches step 4

5th April 2023

Since 2005, the ICH Q9 Guideline on Quality Risk Management has represented the state of the art. A revision was announced at the end of 2020. In January, this revision has reached stage 4 and is now moving into implementation.

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EMA - DARWIN EU® has completed its first studies and is calling for new data partners

29th March 2023

DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded. The network also initiated its first four studies using real-world data (RWD) from across Europe to better understand diseases, populations and the uses and effects of medicines.

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EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023

29th March 2023

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023

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