NEWS & POSTS

Are you ready to launch?

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 Nordic VNR and similar

– Local review and approval of educational materials, when available

– Ensuring PV and GDP functions are in place, in accordance with local requirements

– Review and adaption of promotional material according to local ethical code

– Registration in local data bases and update of compendia such as Fass in Sweden and Felleskatalogen in Norway

At RegFile we are happy to support with the regulatory launch activities for the five Nordic countries. Contact info@regfile.se for more information.

What about some regulatory medical writing

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 Scientific Advice and more.

Let us help you compile a comprehensive overview of your scientific results and conclusions or just give your “drafty draft” the final professional touch.

Learning with RegFile: eCTD overview

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)

Merry Christmas! God jul! Happy holidays!

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

Jobba med oss

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

Open position #1

 

 

New year. New regulations.

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:

 

CTIS
On Jan 31, 2023, The Clinical Trials Information System (CTIS) will become mandatory for submission of Clinical Trials in Europe. Sponsors can use CTIS to apply for authorisation to run a clinical trial in up to 30 EEA countries via a single on-line application.

Variations application form
A second release of the web based Human Variations electronic application form is planned for March 2023 and will support all types of EU variation procedures (both CAPs and NAPs). The release will be followed by a 6-month transition period during which both the PDF eAF and the web-based form can be used in parallel.

 

DSCSA
In November 2023, the FDA Drug Supply Chain Security Act (DSCSA) comes into effect. The act outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. There are four important requirements to be aware of; product serialisation, product tracing, verification (of product identifiers), authorised trading partners.

RegFile AB
Eklundshovsvägen 1G, 

752 37 Uppsala, Sweden 

info@regfile.se

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