|
|
 |
|
|
|
|
|
|
News from ICH
|
The ICH Q12 "Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management Introductory Video" has been published on 4th March 2024 following the publication of the ICH Q12 Module 8
in February 2024. The Introductory Video and Q12 Module 8 can be
found on the Quality Guidelines Webpage
... more
During the seminar "Mastering ICH Quality Guidelines: From Development to Lifecycle Management" on 28 November 2024, you will receive a guide for the beneficial implementation of the requirements of the ICH Q12 guideline.
Details
|
|
|
|
|
|
|
|
|
|
News from European Commission |
|
On April 10th 2024 the plenary of the European parliament has adopted its position on the revised EU pharmaceutical legislation.
Details
EU Commission published a methodological guideline for quantitative evidence synthesis: direct and indirect comparisons in the context of EU HTA.
Details
We recommend the German speaking course on Joint Scientific Consultation and Joint Clinical Assessment in the context of EU-HTA: EU-HTA: "Dossiervorbereitung und Joint Scientific Consultations".
Details
|
|
|
|
|
|
|
|
|
News from EMA |
|
The draft guideline “on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials” can be commented on by 31 May 2024.
Details
|
|
|
|
|
|
|
|
|
|
|
|
|
News from BfArM and PEI |
|
In response to the challenges faced in providing sufficient clinical data for allergen products, especially when patient numbers are low, such as for rare allergies, the European Medicines has published the draft for a specific guideline. This guideline, developed with input from the Paul-Ehrlich-Institut, outlines how to provide adequate scientific evidence for the approval of diagnostic and therapeutic allergens during product development when limited patient populations are available for clinical studies, and is open for comments until May 31, 2024.
Details
The bulletin on drug safety in issue 1/2024 has been published.
Details
In addition to postal applications, since the end of January 2024 it has been possible for doctors, pharmacists and dentists to apply for EU certificates of conformity in accordance with EU Directive 2005/36/EC online via the federal portal.
Details
|
|
|
|
|
|
|
|
|
|
|
|
|
Kind regards,
|
Dr Rebekka Bitsch
Your contact for
Regulatory Affairs (Human)
+49 6221 500-565 |
Dr C. Michaela Gottwald
Your contact for
Regulatory Affairs (Veterinary)
+49 6221 500-610 |
Dr Birgit Wessels
Your contact for
CMC
+49 6221 500-652 |
|
Verena Planitz
Your contact for
Global Regulatory Affairs
+49 6221 500-655
|
|
|
|
|
|
