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Oncology: Evidence, HTA and Reimbursement
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Author: Dr Henriette Wolf-Klein, FORUM Institut für Management GmbH
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The "Oncology: Evidence, HTA and Reimbursement" conference 2023 took place on 27 and 28 February 2023 - online. Dr Markus Follmann, German Cancer Society, addressed current possibilities of evidence assessment, especially through the GRADE methodology and the HTA tool of the OL Office (OL = Guidelines Programme Oncology).
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| News from the ICH |
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ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
Currently, the anticipated finalisation date of ICH M13A is May 2024.
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| News from the EU Commission |
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Laurent Muschel has been announced as new head of Health and Emergency Prepardenes and Response Authority (HERA).
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| News from CMDh |
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Impurity chloromethyl isopropyl carbonate (CMIC) in tenofovir disoproxil-containing medicinal products: Following a review of available data including in vitro studies by the Non-clinical Working Party, the impurity chloromethyl isopropyl carbonate (CMIC) is now considered to be a class 2 mutagenic impurity according to ICH M7.
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| News from the EMA |
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EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices.
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| News from BfArM and PEI |
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The statistics on the marketable medicinal products of the special therapeutic indications (phytopharmaceuticals, homeopathics, anthroposophics) as well as traditional medicinal products that have successfully completed a (post-)authorisation or (post-)registration procedure have been updated.
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The online seminar “Phytopharmaka & Homöopathika: Regulatory-Affairs-Essentials” takes place on 20 June, 2023. You will be able to work on applications for marketing authorisation. You are informed about the different procedural options and can accompany them.
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From 31.01.2023, applications for new clinical trials must be submitted centrally via the Clinical Trials Information System (CTIS).
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Within the scope of the webcast series biologics Katharina Mayer will contribute with a session with focus on “The new Clinical Trial Regulation and the Go-Live of Clinical Trial Information System (CTIS)” on 19 September 2023.
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The Federal Health Bulletin – Health Research – Health Protection is a monthly health science journal whose editorial office is located at the Robert Koch Institute. The editors are the Federal Institute for Drugs and Medical Devices (BfArM), the Paul Ehrlich Institute (PEI), the Federal Center for Health Education (BZgA) and the Robert Koch Institute (RKI). New release: Volume 66, Issue 2, February 2023 "Technical, legal and ethical framework conditions of digitalization in healthcare – highlights of an accelerated development".
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| News from the EDQM |
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The European Pharmacopoeia (Ph. Eur.) Commission decided to create a new Working Party on High Throughput Sequencing (HTS), in charge of elaborating a general chapter on HTS for the detection of viral extraneous agents.
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The European Pharmacopoeia Commission creates new Excipients Strategy Working Party: The EXS Working Party will focus on continuing to address the specificities of these important pharmaceutical ingredients in European Pharmacopoeia (Ph. Eur.) monographs and will also reflect on how best to further develop the Ph. Eur. excipient strategy.
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| Veterinary news |
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The draft-Guideline “on plasmid DNA vaccines for veterinary use” can be commented on until 23 June 2023.
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Kind regards,
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Dr Tatjana Mende
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
Quality, Safety, CMC
+49 6221 500-652 |
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