Report describing communication plan and governance

Task 5.3: Engage HCPs, pregnant and breastfeeding women and general public and to stimulate pregnancy reporting through PV system and participation in research; (with WP2, WP6 and WP7) (M6-M60) (NUTH, ENTIS, LAREB, Synergist, UPPS, EIWH, (third parties such as EU organisation for GPs/ gynaecologist /midwives/pharmacists) Pfizer, Sanofi, NVS, AbbVie, UCB) Rationale: Based on the ethical discussions in WP7 (task 7.3) about the idea of a learning healthcare system where we have a moral duty to generate evidence on the use of medicines in pregnancy, we will translate the learnings from the ethical research into communication programs to stimulate HCPs and pregnant women awareness that they have can play an active role in increasing general knowledge about the safety of drug use during pregnancy and breastfeeding in the post-marketing phase of a drug by contributing to WP2 as well as WP4. Aim: To build awareness and stimulate actual participation from the targeted audience Method: Communications directed to relevant stakeholders will be developed using push-pull strategies and developing value propositions. A combination of very targeted communication on social media and other digital channels together with point of care material will disseminate the message and capture the audiences utilising health literacy methods and tailored messages to stimulate their participation. The campaign overarching messages will build on various awareness messages and value propositions for pregnant women and HCPs. Each exposure will be the opportunity to engage and offer participatory mechanisms. Messages and value propositions will be tested ahead and then will be assessed in terms of participatory rate and ultimately behaviours changes, partly measured through the channels we will deliver (online, apps, etc.) In the same countries as the information materials are tested, communication strategies (including through social media, promotion through pharmaceutical companies, national healthcare systems and international/national regulatory organisations) will implemented to inform the general population, pregnant women/women of reproductive age and healthcare professionals about the importance of reporting to the pregnancy pharmacovigilance system. The effects of the campaign will be measured, both in terms of increased reporting, but also in terms of increased awareness about the importance of reporting among HCPs.