|Date & Time||5 October 2022 at 10:00-12:00 CEST|
EATRIS Sweden and RegSmart Life Science Consultancy are hosting a free training seminar on regulatory knowledge aimed for researchers/professionals who wish to know more about the development of products in the life sciences. You will learn from ex-regulators how regulators think, and we will guide you through the regulatory landscape. After the seminar, you will have a clearer understanding of how to turn your research into efficient product development, always with the end in mind. Take the opportunity to learn more about:
- How to take your product to the market, you have to decide what kind of product it is, i.e. which regulatory framework to follow. Why this is important and how to choose.
- How do you prove that your medical device complies with the regulations? The concepts of safety and efficacy as well as risk/benefit assessment, and a brief note on quality management systems – why and when? What is a clinical evaluation, and how can it be used to add value in my product development?
- Learn more about how to take advantage of establishing a TPP, target Product Profile, early in the development. How do you plan your development program to obtain an effective and safe product, with suitable quality, that can be approved by the regulatory authorities and meet the market needs?
Do not miss out on the opportunity that 10 researchers/companies attending the training webinar will be offered a one-to-one meeting with one or two regulatory specialists to discuss a regulatory strategy for their specific product. These meetings are for free and will be supported by the Swedish EATRIS node.
About RegSmart Life Science and the lectures:
RegSmart Life Science is a regulatory consultancy firm in pharma and medical device that will help the researchers to navigate in a complex and evolving regulatory landscape. They have a long regulatory experience from senior positions at a regulatory agency and from small and big life science companies we facilitate your work by knowing ”what to do, when and how”. RegSmart provide fit for purpose advice and support in relation to European and US regulatory requirements, helping to develop a regulatory plan as part of your overall project strategy. Their expertise is to analyse and interpret the guidance provided and decisions taken by regulatory agencies in EU and US and help answer the specific questions in your projects with support from early research throughout your product life-cycle, always with the target product profile in mind.
Anna Wannberg Senior consultant
Anna is a pharmacist with a PhD in toxicology. She joined RegSmart in the end of March this year with a focus on MDR and IVDR and different regulatory issues such as borderline, clinical/performance evaluation and trials, and responsibilities of different economic operators. Anna has a pharmaceutical background and holds a PhD in toxicology. She has a long regulatory background and has worked for the Swedish Medical Products Agency (MPA) for years with a focus on regulatory questions for medical devices, such as the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) in national legislation, borderline and classification, but also market surveillance. Furthermore, she has been working with preclinical validations of clinical investigations for medical devices and served as preclinical assessor reviewing market authorization applications for herbal medicinal products. Anna has also experience from the Swedish Food Agency and the Swedish Chemical Inspectorate.
Karin Westermark Senior consultant
Karin has a PhD in physics/physical chemistry and has a wide technical knowledge. In early 2022 she joined RegSmart, where she supports with MDR submission and postmarket surveillance, as well as finding regulatory pathways to bring new products to the market. Before starting at RegSmart, she worked at the Swedish Medical Products Agency for six years. She was responsible for market surveillance cases involving medical devices, including in-depth reviews of documentation and working in cross-functional teams. She also worked with implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and served as Sweden’s representative in the EU Commission’s group for the Unique Device Identifier (UDI).
Robert Hägerkvist Senior consultant
M Sci Pharm, Ph D
Robert is a pharmacist with a PhD in medical cell biology. Robert has been with RegSmart for 1.5 years and participates in several small pharma project groups. Robert has also been advising in several incubator led initiatives for academia. Previous to RegSmart, Robert spent eight years as a clinical assessor at the Swedish Medical Products Agency. As a clinical assessor he has reviewed a number of market authorisation applications as well as providing scientific advice to companies. He has extensive knowledge in regulatory pathways in the pre- and post-marketing setting.