EMA publishes Updated Version of Good Clinical Practice (GCP) Q&A

2022-08-25T10:19:19+00:00April 4th, 2022|Categories: Clinical Trial, Compliance, Europe, Regulatory|Tags: , , , , , , , |

EMA has published an updated version of its good clinical practice Q&A The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of [...]

Spain: AEPD Approves 1st Industry Code of Conduct to Enable Compliance with the GDPR

2022-08-26T08:10:42+00:00March 11th, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: , , , , , , , |

Spain: AEPD approves the first industry code of conduct to enable compliance of clinical research and pharmacovigilance with the GDPR The Spanish Data Protection Authority (AEPD) has recently approved the first industry code of conduct (CoC) under the [...]

FDA Finalizes Guidance for Premarket Pathways for Combination Products

2022-08-26T09:16:03+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: , , , , , , |

US: The FDA has finalized guidance on the use of premarket pathways for combination products The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the [...]

PREFER patient input to decision making under evaluation

2022-10-06T11:12:50+00:00October 16th, 2021|Categories: Digital Health, Europe, Regulatory|Tags: , , , , , , |

PREFER patient input to decision making under evaluation PREFER project has developed a framework with points to consider when selecting methods for industry, regulators and health technology assessment bodies for how to use patient preferences as input in medical [...]

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

2022-10-06T12:45:59+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: , , , , , , , , , , , , , |

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex [...]

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