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The Clinical Overview is one of the most important documents on your way to Marketing Authorisation. It is an in-depth critical analysis of your complete drug development programme and its results, including discussion and interpretation of clinical findings. The overview presents the strengths and limitations of your programme and study results and analyse clinical benefits… Fortsätt läsa Clinical overview – eCTD module 2.5

5 tips1.      Make sure a Change Control (CC) case is opened and that a project is set up, together with relevant co-workers. This is important, also for smaller changes. 2.      Correct classification is key. Study the classification guideline carefully and ask a colleague for advice if you feel unsure. For non-standard variations, always confirm the classification with… Fortsätt läsa How to succeed with CMC variations

Strong scientific skills– Literature/reference searching– Critical review of scientific literature and reports Strong written communication skills– Accurate and thorough summaries– Comprehensive and clear messages– Correct Medical terminology Strong analytical skills– Interpretation of research data and statistics– Visual presentation of data (diagrams, tables, graphs) At RegFile we are happy to support you with your Medical Writing.

When your Marketing authorisation is granted, many local regulatory activities are still required prior to commercial launch. These requirements vary significantly between countries, and we recommend you to carefully plan the marketing in collaboration with local experts. Below some actions that usually involve Regulatory Affairs: – Strategy for common packs and serialisation – Application for… Fortsätt läsa Are you ready to launch?

A regulatory Medical Writer combines knowledge in both writing and science to produce fit for submission documents in compliance with current guidelines, templates, and standards. The RegFile team support you in producing high quality documents ready to be shared with agencies, such as: clinical and non-clinical overviews and summaries, Periodic Safety Update reports,Briefing documentation for… Fortsätt läsa What about some regulatory medical writing

RegFile’s next contribution to Kunskapsportalen is the presentation ”eCTD overview”. Kurskatalog (learnifier.com)Kunskapsportalen is a platform created by SweLife and contain trainings within product development, , business development, specific regulations and intellectual property. Swedish incubators and innovation offices are behind the initiative. Read more: https://swelife.se/kunskapsportalen-sjosatt%ef%bf%bc/Create an account in Kunskapsportalen: Kurskatalog (learnifier.com)

Thank you for a great first year in business. We are longing for 2023!

Vi söker förstärkning inom regulatory. Har du några års erfarenhet från industri eller myndighet – välkommen att söka! Se hela annonsen här:  Open position #1    

Do you know what is happening in regulatory next year? 2022 is coming to an end and we are looking forward towards 2023. Here we list some important regulatory changes:   CTISOn Jan 31, 2023, The Clinical Trials Information System (CTIS) will become mandatory for submission of Clinical Trials in Europe. Sponsors can use CTIS… Fortsätt läsa New year. New regulations.