NEWS & POSTS

Kunskapsportalen – EU marketing authorisation procedures

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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Meet us at the CTR stand at NLS days in Malmö

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!

Åsa Jansson to RegFile

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 to RegFile

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!”

Maria Nilsson Hagberg to RegFile

We are so happy to welcome Maria Nilsson Hagberg to RegFile! With some 20 years of experience from regulatory affairs in pharma industry and as a consultant Maria will have a given role as a senior regulatory consultant and also a part of the RegFile management. Maria has a wide experience from clinical trial applications and scientific advice, marketing authorisations and variations and more. Her expertise and motive force will be an amazing asset to us and our clients and partners.

 

 

”I am so excited about my new position at RegFile. What really interested me was the possibility to join the set-up of a flexible and quick regulatory consultancy with all the benefits of a small company that at the same time has access to fantastic expertise both internally and within the CTR group. I like to work closely to the clients and enjoy the constant challenges within the regulatory affairs field. And last but not least I look forward to again be able to work with my talented ”work-wife” Maria Santesson!”

CTR launches podcast together with SwedenBIO

The first episode of the podcast Idé till patient (Idea to patient) will be released on April 12.

The podcast series is a co-production between the companies within the CTR-group and SwedenBIO. The series comprises six episodes where invited guests from the pharma industry will be discussing the pitfalls and highlights in early drug development. Episodes 2-4 will mirror the way to clinical trials and episode 5 will comprise discussions about the first-in-human trial.

 

 

“We will discuss important keys in how to go from idea to patient. We highlight the importance of having a TPP early on, need to plan for toxicology early, how to interpret guidelines and how to choose starting dose in your first in human study”, says Karin Meyer, CEO at CTR.

 

 

“SwedenBIO encourage member companies to share knowledge and experiences with each other in the Life Science community and we are happy to launch this podcast with the CTR companies. The translational phase from idea to a new treatment for the patient is complex. With the podcast we hope to untangle the obstacles in an easy-going way”, says Frida Lawenius, Deputy Director General at SwedenBIO.

 

 

Center for Translational Research Sweden

 

 

CTR was founded 2016 and is a group of complementary life science service companies engaged in translational research. CTR is the owner of Clinical Trial Consultants, RegSmart Life Science, RegFile, Lablytica Life Science and Toxicology Knowledge Team Sweden.

 

 

SwedenBIO

 

 

SwedenBIO is the national non-profit association for the life science industry in Sweden, with more than 300 members. Sweden has an innovative life science industry, strong academia and world leading infrastructure for research. SwedenBIO’s members are companies active within pharma, biotech, diagnostics and medtech and comprise the entire range from small start-ups, to SMEs and large enterprises. Many are engaged in research and development. Other members are experts in fields such as IP, law, finance, product development, life science communication, and business development.

RegFile AB
Eklundshovsvägen 1G, 

752 37 Uppsala, Sweden 

info@regfile.se

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