The OHDSI Sweden community is building the OMOP data model
The adoption of the OMOP Common Data Model, which aims to harmonise health data, is still at an early stage in Sweden, but progress is rapid.
Medaffcon’s Medical Affairs team provides agile expert support for the review of marketing materials for pharmaceutical companies and other healthcare organizations across the Nordic region. The service includes consultation during the material planning phase, as well as the actual medical and regulatory review of various marketing materials.
Medaffcon has developed this service under the leadership of Medical Affairs Lead Kristiina Pelli. The company has more than ten years of experience in Finland, and today marketing materials for Nordic clients are also reviewed by Medaffcon’s Swedish subsidiary.
“Companies can outsource the review of marketing and other materials to Medaffcon, allowing their internal resources to focus on other priorities. There may also be a need for specialized expertise, which Medaffcon has accumulated through a wide range of projects,” says Pelli.
The review of marketing materials involves assessing brochures, websites, advertisements, presentation materials, and other communications before publication. The review applies to materials intended for authorities, healthcare professionals or the public.
Each review assignment is supported by a team of experts, providing the capacity and continuity needed to meet even tight customer timelines.
“We work flexibly as an integrated part of the customer’s brand team throughout material preparation, using the customer’s online document and review tools or collaborating by email when needed. Our experience shows that these partnerships often continue for years, as they streamline the review process and free internal medical and other resources to focus on business-critical, customer-facing activities,” says Pelli.
The review process ensures that all claims are supported by sufficient scientific evidence and approved Summary of Product Characteristics (SmPCs), that the presentation is not misleading, and that all applicable laws, regulations, and industry self-regulatory codes are complied with. For example, in Finland this includes guidance and ethical rules issued by the Finnish Medicines Agency (Fimea) and Pharma Industry Finland (PIF).
The review process includes, among other things, evaluating the tone and wording used, verifying the accuracy of images and graphics, reviewing any competitor comparisons, and ensuring that communications relating to prescription medicines and non-prescription (OTC) medicines are clearly distinguished from one another.
“This work combines regulatory expertise, attention to detail, and a strong sense of responsibility. Every detail can influence how trustworthy pharmaceutical communications are perceived to be,” says Pelli.
The adoption of the OMOP Common Data Model, which aims to harmonise health data, is still at an early stage in Sweden, but progress is rapid.
Disruption is present in many forms, and our clients are facing new challenges that require them to adapt to new ways of working. The same applies to us.
In a data gap analysis, gaps in the available information of the therapy area and data on a medicinal product are mapped and assessed against regulatory, scientific, and business requirements.
Medical Affairs Lead
MSc (Food Science), MBA
+358 40 510 0838
kristiina.pelli@medaffcon.com
Kristiina joined Medaffcon as a Business development manager in 2012. She started her career in a CRO, after which she worked in scientific advisor and line manager positions in two large pharmaceutical organizations, now reaching already 15 years in the business. Kristiina holds master’s degrees in both Nature Sciences and Business (Henley MBA).
At Medaffcon, nowadays as a Medical Affairs team lead, Kristiina leverages her long experience from various stakeholders in the business and her vast therapeutic area expertise in close collaboration with her team to the benefit of customer assignments. When asking what the best part of this work is, she refers to the fast change and the continuous strive for the better, for all of us, as health care service utilizers. ”Every year, I feel that never before have we been working on such vast and important topics and yet, next year the feeling is the same again”.