Nordic Life Science Events in February 2022
What is happening in the Nordic Life Science arena in February 2022? In this update, we list the events and webinars in the Nordics that we think all biotechs’ in their early stages should keep an extra eye on. We hope you do too!
Health care’s most important path: The antibiotic challenge
How do we increase knowledge and awareness of antibiotic resistance and how do we slow down development? This year’s first event, provided by Lif, “Vårdens viktiga vägval” addresses one of the major global public health threats – antibiotic resistance, sometimes also called the silent pandemic.
Date: 2nd of February
This event will be held in Swedish
MVA Inspirational Webinar Series – Assessing treatment efficacy in early-phase oncology trials
One of the major recent trends in drug development in oncology, particularly with highly targeted therapy and immunotherapy, is a great concern with efficacy assessment in the early phases of development. This was not frequent before the era of precision medicine. As a result, phase 1 trials now routinely have efficacy endpoints and even sample-size justification related to efficacy, particularly in expansion cohorts. This online webinar, provided by Medicon Valley Alliance, will present a historical overview of efficacy assessment in early-phase trials, highlight some recent regulatory trends in that respect, discuss the tension between the clinically appealing and statistically sound methods to assess the efficacy of novel treatments in phase 1 trials, single-arm phase 2 trials, and randomized phase 2 trials.
Date: 3rd of February
Introduction to MDR for Class 1 manufacturers: Part 1
Together with the Medical Products Agency, Swedish Medtech organises a free webinar (two parts) on the medical technology regulations, MDR (Medical Device Regulation). This webinar series is aimed at those who have Class I products and who need a first introduction to the regulations. In this first part of the series, “Pre-market”, you get to learn about laws, rules and guidelines to know and relate to, the role of “manufacturer” and “person responsible for compliance” (PRRC), the intended use of the product and its significance, qualification and risk classification of medical devices, requirements for the quality management system, the risk management system and the technical documentation and marking, instructions for use, UDI, language requirements and symbols.
Date: 3rd of February
MVA Microbiome network meeting: Live biotherapeutic products – From early discovery to manufacturing
Medicon Valley Alliance has joined together with Bacthera, to organise the Medicon Valley Alliance Microbiome Network meeting. The network meeting will focus on strategies and processes for developing and manufacturing of Live Biotherapeutic Products (LBPs). In the meeting, various experts will provide their insights addressing practical aspects of manufacturing and the complex regulatory environment as well as give examples from companies sharing their experiences of developing LBPs.
Date: 9th of February.
The event will be held in Copenhagen
Wednesday Breakfast with Setterwalls
Join SmiLe Incubator IRL or via Zoom and stay up to date with the latest news from their community, sponsors and coaches.
Date: 16th of February
Introduction to MDR for Class 1 manufacturers: Part 2
Together with the Medical Products Agency, Swedish Medtech organises a free webinar (two parts) on the medical technology regulations, MDR (Medical Device Regulation). This webinar series is aimed at those who have Class I products and who need a first introduction to the regulations. In this second part of the series, “Placing on the market & Post Market Survelliance”, you get to learn about the product life cycle and maintenance of technical documentation, the interplay between risk management, clinical evaluation and monitoring of products placed on the market (“PMS”), the players in the supply chain, marketing and traceability and the Swedish Medicines Agency’s role, supervision and shortcomings in supervision
Date: 24th of February