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eCTD Industry Update (21st February 2023)

February 21, 2023
/
onix

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 herbal medicinal products within the EU medicines legislation
  • Template or form: Day 80 assessment report - Overview and D120 LOQ template with guidance - Rev. 02.23 (updated)
  • Submission deadlines for orphan designations (updated)
  • Other: Multilingualism on the EMA website and in external communications
  • Other: Languages on this website
  • Other: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP) (updated)
  • Other: Questions and answers by the Query Management Working Group on CTIS and the CTR (updated)
  • Clinical Trials Information System (CTIS) bitesize talk: Annual safety report (ASR) , Online, 16:30 - 18:00 Amsterdam time (CET) (Updated), from 15/12/2022 to 15/12/2022 (updated)
  • Product Management Service (PMS) Webinar on Data Migration , Online, 14:00 - 15:30 Amsterdam time (CEST), from 23/02/2023 to 23/02/2023 (updated)
  • EIC / EMA Info Day: Regulatory support for the development of innovative medicines and technologies , Online, 09:00 - 12:30 Amsterdam time (CET), from 31/01/2023 to 31/01/2023 (updated)
  • 3Rs Working Party (3RsWP) plenary meeting - Public session on the 2023 work plan , Online, from 28/02/2023 to 01/03/2023
  • Advanced therapy medicinal products: Overview (updated)
  • Clinical Trials Information System (CTIS) bitesize talk: Document and personal data in CTIS , Online, 14:30 - 16:00 Amsterdam time (CET), from 23/02/2023 to 23/02/2023 (updated)
  • Herbal medicinal products: questions and answers (updated)
  • Herbal - Call for data: Call for scientific data for use in HMPC assessment work on Cannabis sativa L., flos (Cannabis sativa flowering tops)
PreveCTD Industry Update (13th February 2023)
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ONIX Life Sciences Ltd, 59-60 Thames Street, Windsor, Berkshire, SL4 1TX.

ONIX Life Sciences Inc, 500 Delaware Ave, Ste 1 #1960, Wilmington, DE 19899, USA

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