The conditions and needs of smaller research and development companies regarding clinical trials differ in several respects from those of larger players. While the large companies in the industry already have established contact areas with the Swedish Medical Products Agency, there has so far been no arena for dialog and knowledge transfer between the agency and the smaller companies in drug development and medical technology.
The purpose of the dialogue forum – which is the first of its kind in Sweden – is to capture current and tangible issues regarding the concrete implementation of clinical trials, but also to reach out to those whom the Authority does not reach today, with information initiatives, knowledge and seminars. Ultimately, this creates better conditions for conducting clinical trials in Sweden.
“Both authorities and industry organizations are contributing to the national life science strategy and want to speed up its implementation,” says Björn Eriksson, Director General of the Swedish Medical Products Agency.
“By increasing dialogue between authorities and smaller pharmaceutical and medical device companies, we can improve the understanding of regulatory requirements. This, in turn, will give patients and healthcare providers faster access to new and innovative products,” he continues.
Frida Lawenius, Vice President of SwedenBIO, says: “With this contact area, we want to increase knowledge and understanding of the conditions and needs of smaller companies at the authority, but also create a dialog on issues related to the development and new initiatives.”
“My hope is that this dialog will lead to faster and smoother processes for the smaller companies in clinical trials, which is something that is requested by SwedenBIO’s members. Better processes mean shorter lead times and make Sweden a more attractive country in which to conduct trials”, continues Frida Lawenius.
The dialog forum is run by a group consisting of regionally dispersed companies from SwedenBIO’s member base and representatives from the Swedish Medical Products Agency.
One of the participants in the group is Jennie Ekbeck, CEO of Umeå Biotech Incubator and representative of the Association of Life Science Incubators of Sweden (ALIS).
“Increasing the ability of SMEs to conduct clinical studies is important for Sweden’s international competitiveness. It is also important that the smaller companies have the opportunity for a close dialog with the authority, which is the goal of this dialog forum”, says Jennie Ekbeck.
Seminar series on regulatory processes
The Forum provides a channel for the Agency to reach out to companies with information. The series of seminars on regulatory processes that the Swedish Medical Products Agency’s innovation office and SwedenBIO are now conducting is a first example of information efforts that will be carried out within the framework of the forum.
The seminar series marks the start of the collaboration and consists of four digital lunch seminars starting on May 24. The Medical Products Agency’s lecturers will go through the regulatory processes from testing to approval. The seminars are open to all, but are mainly aimed at smaller pharmaceutical and medical device companies.
The series includes the following seminars:
- Regulatory framework for drug approval (Tuesday 24 May, 11:30-13:00)
- Strategic and Practical Aspects of Drug Authorization (Tuesday 31 May, 11:30-13:00)
- Regulatory framework for human clinical trials (Tuesday 7 June, 11:30-13:00)
- Clinical trials of medical devices (Tuesday, June 14, 11:30-13:00)
More information and registration forms are available on the Agency’s website.
