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Vi söker förstärkning inom regulatory. Har du några års erfarenhet från industri eller myndighet – välkommen att söka! Se hela annonsen här:
Vi söker förstärkning inom regulatory. Har du några års erfarenhet från industri eller myndighet – välkommen att söka! Se hela annonsen här:
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.
Vi är stolta och glada att få vara med och bidra till Kunskapsportalen med två kurser för innovatörer inom life science. Kunskapsportalen är en plattform med utbildningar inom ämnen inom som produktutveckling, immaterialrätt, specifika regelverk och affärsutveckling.
Det är SweLife tillsammans med svenska inkubatorer och innovationskontor med life science-inriktning som står bakom initiativet. Läs mer här: https://lnkd.in/eHGvVaQ4
Skapa konto i Kunskapsportalen: https://lnkd.in/d6-hk5fw
Först ut av RegFiles bidrag är ”Procedures for EU marketing authorisations”: https://lnkd.in/d6pCCgXm
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Nordic Life Science Days is one of these yearly events we look forward to the most. It is usually very well-organised with a lot of networking opportunities. This time RegFile will be sharing booth with friends from the CTR Group. You are welcome to drop by the multicoloured puzzle for a chat and some sweets.
See you there!
We are strengthening the group within medical & regulatory writing. Åsa with her particular interest in writing scientific texts on complex subjects, will complement RegFiles perfectly. She has a Ph D in immunology and is experienced in drug development and in the writing of scientific overviews.
”It feels exciting and stimulating to work with such experienced and professional colleagues at RegFile – a small team with big muscles. The fact that we are also in a larger context with the sister companies in the CTR group gives us additional competence and strength. It’s great to be working with drug development again!”
Lina Påve is a regulatory CMC specialist. After many years as a quality assessor at the Swedish Medical Products Agency, she has solid experience in assessing module 3 documentation for a wide range of pharmaceutical substances and formulation forms. With her skills she becomes an important part of the team when we help our customers with gap analyses, scientific advice, and applications for marketing authorisation.
”I am really excited to be part of RegFile, a new company with a lot of commitment – and at the same time has such an experienced and knowledgeable team. The fact that we have offices in the beautiful Eklundshof next to the Uppsala Science Park and the Medical Products Agency is also a plus!”
RegFile AB
Eklundshovsvägen 1G,
752 37 Uppsala, Sweden
info@regfile.se
