Medicines may be priced freely for up to one year following marketing authorisation. However, a benefit dossier must still be submitted to the G-BA at launch. All medicines with marketing authorisation are reimbursed; however, the reimbursement level is based on "additional benefit" determined by the G-BA and negotiated with GKV-SpV.

Reimbursement decision-making is highly centralised, being conducted by NICE according to defined cost effectiveness thresholds; however, regions and individual hospitals must manage their healthcare budgets and are therefore also key stakeholders in the reimbursement process.

Although there is a national pricing and reimbursement process in Italy, regions control their own budgets and formularies.

BEBPA HCP 2019 -- The most critical part of developing an ELISA for measuring Host Cell Protein (HCP) impurities in Biotherapeutics is generation of specific antibodies with appropriate recognition of the total population of HCPs potentially present in the product.

Learn how patient participation and retention consistently met expectations throughout a fifteen-year study.

Site-based observational research has many challenges. Considerable time and cost is invested in identifying suitable sites and investigators, and then managing them to ensure recruitment and research are conducted in line with the protocol and local review board requirements.

Global Reach, Local Touch. Learn how FSP solutions can be customized to ensure project success.

In an era of continued pressure on healthcare budgets, the role of health economic data has never been more important. Yet the contribution these data make to rational decision-making can be undermined by incomprehension, skepticism and even hostility from outsiders - including colleagues, commentators and healthcare decision-makers.

In recent times, pharmacovigilance regulations have focused increasingly more on medical literature monitoring (MLM), a complex process whose scope continues to expand and deepen. **Disclaimer: This article was previously published. Sciformix is now a Covance company.