All prescription drugs produced after 2019-02-09 must be provided with safety features. This is, a little simplified, the meaning of the new EU directive FMD or Falsified Medicines Directive, 2011/62 / EC.
To know how companies can and should act for the introduction of the regulatory framework, Sigma is now helping companies by organizing lectures on FMD. Responsible for the lectures are specialists from Sigma Quality & Compliance and the communication agency Maverick by Sigma.
Lena Bergström from Sigma Quality & Compliance and Elin Mellbrand from Maverick by Sigma will lead the lectures on labeling, marketing and communication of prescription drugs to meet FMD, to help you get ready in time.
– We see that many companies have not yet started to work with these issues and that’s why we want to spread knowledge about FMD, says Elin Mellbrand, Communication Strategist, specialized within Life Science at Maverick.
– The new regulations affect how companies' packages should be designed and thus also Regulatory Affairs, says Lena Bergström, Senior Consultant specialized within Regulatory Affairs.
Many pharmaceutical companies have so far focused on getting the technology in place, and therefore not been able to allocate time or resources, to consider artwork, communication to the customer management team, or what type of application is required for approval of a package that is provided with security features. It's high time to get everything in place – The Falsified Medicines Directive, FMD will apply as of 9th February 2019.
"How FMD affects labeling, marketing and communication of prescription drugs" is the title of Sigma's lecture in Gothenburg, Malmö and Stockholm.
2018-06-12, 17:00 - 18:00 Malmö, Sigma, Dockplatsen 1, 5th floor
2018-06-13, 17:00 - 18:00 Gothenburg, Sigma, Lindholmspiren 9, 5th floor
2018-06-14, 17:00 - 18:00 Stockholm, Sigma, Valhallavägen 117
The lectures are free for the participants, but Sigma would like you to register, as the number of seats is limited. The application is made to firstname.lastname@example.org
More lectures are scheduled for September 2018.
For more information
Tina Rudin Kaikkonen
Business Manager Maverick by Sigma
+46 739 28 3632
Communications and Culture Director, Sigma IT Consulting
+46 703 79 1506