Synetic

The presentation outlines the importance of establishing an integrated approach in evidence generation to deliver a unified value proposition and discusses the challenges that an organisation must overcome when there is not such an approach in place. Finally, we lay out a set of benefits that pharmaceutical companies can realise from establishing of an IEGP […]

Pharmaceutical companies need to patient and financial value through the development and commercialisation of products. This requires a clear strategy with robust product planning, execution and tracking. The purpose of this presentation is to describe the key elements that need to be considered in order to optimise product strategy and planning.

Regulatory Affairs organisations interface with many internal and external stakeholders and will need to continue to respond to a dynamic and evolving environment. We outline 5 priorities that Regulatory Affairs organisations must explore in order to prepare for the future:​ Enhance the Regulatory Affairs and Pharmacovigilance interface​ Optimise outsourcing ​ Prepare for new modalities​ Drive efficiencies and quality through automation​ Explore machine learning

Technological developments and the ever increasing breadth and depth of new information and evidence being generated have driven many life sciences companies to focus on making information accessible to external stakeholders across multiple channels in a seamless way – often referred to as ‘omnichannel strategy’. However, there is often too much focus on technology and not on the strategic

Decentralised Clinical Trials (DCTs) present a biopharmaceutical company with a series of opportunities and challenges. We highlight the challenges and examine the value the individual DCT elements may create for patients, investigators and site staff, regulators and ethics committees, and the sponsor. We also contend that for a DCT to be truly patient-centric, the patient must be provided with

The purpose of this paper is to describe how effective Medical Affairs KPIs can be developed as straightforwardly as possible, and to present key elements that organisations should consider in their own KPI dashboards.​ The paper is broken into two main parts:​ The first section outlines a framework for how a suite of Medical Affairs KPIs can be built from

As Medical Affairs organisations continue to evolve, the ‘Medical Operations’ or ‘Medical Excellence’ group is becoming increasingly important. This paper explores how Medical Operations groups can best evolve to meet the needs for a fit-for-future Medical Affairs organisation, recognising the emerging opportunities, the needs of different constituent groups within Medical Affairs, and acknowledging the continued

The purpose of this presentation is to describe some key practical considerations and challenges that pharmaceutical companies will need to have in mind with regards to the EU Clinical Trial Regulations.