eCTD NEWS
RECENT NEWS
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EMA: Orphans: Regulatory and procedural guidance and forms (updated): https://bit.ly/3mNjzfG Product-information templates - Human (updated): https://bit.ly/3SQI61z Template or form: QRD product-information template version 10.3 (updated): https://bit.ly/3SyQu61 Template or form: QRD product-information annotated template (English) version 10.3 - highlighted...
CMDh New - Template for Applicants to Prepare Similarity Report Update - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications (Clean / Tracked Version) Update - RMS validation checklist for human medicinal products in DCP Update - Request for MRP/RUP...
EMA DADI PDF electronic application forms (eAF) training webinar, Online, 11:00 - 12:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022 (updated) Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022, from 22/09/2022 to...
EMA EMA Account Management training webinar Quarterly system demo - Q3 2022 Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
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EMA Regulatory and procedural guideline: Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)(updated) Regulatory and procedural guideline: Questions & Answers regarding Cannabis-derived medicinal products and the scope of EU herbal monographs for...
MHRA Completed Paediatric Studies - submission, processing and assessment - 1 February 2023 – Guidance
EMA Clinical Trials Information System (CTIS): online modular training programme(updated) FDA Update on In-Person Face-to-Face Formal Meetings with FDA
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