The new PIC/S guideline on data integrity
30 July 2021 | Giuliana Miglierini

The guideline is intended to support the work of inspectors for the verification of good data management practices and data integrity related to GMP/GDP activities in pharmaceutical manufacturing. Its adoption is not mandatory, and the principles described can apply to all elements of the Pharmaceutical Quality System.

The new vision for the European research landscape
23 July 2021 | Giuliana Miglierini

Many activities are completely reshaping the European research landscape. The European Commission is negotiating with several third countries their participation to Horizon Europe’s projects. Many Science organisations have expressed their position about the current exclusion of Switzerland. Science Europe has published its new Strategy 2021-2026. Five industrial associations in the pharmaceutical and medtech sectors have published a Strategic Agenda for Research & Innovation in Healthcare to guide the new public-private partnerships planned under the proposed Innovative Health Initiative (IHI) framework.

Small-scale models for process development
16 July 2021 | Giuliana Miglierini

SSMs are useful to simulate many different processes typical of biomanufacturing, both in early and late development. A series of articles on BioProcess Online discusses how to approach the implementation and qualification of small-scale models under an industrial perspective.

EMA publishes Q&A document about Parallel Distribution
9 July 2021 | Giorgos Panoutsopoulos

The European Medicines Agency (EMA) has published a new document entitled “Frequently asked questions about parallel distribution” (EMA/297155/2021). The 30-page PDF file contains answers to the most common questions. .

EIPG Virtual Symposium
The Post-COVID Era and Pharmacy
2 July 2021 | Jane Nicholson

Luigi Martini, Chief Scientist at the Royal Pharmaceutical Society chaired an EIPG Symposium on the lessons learned from the pandemic and how pharmacists can shape the future in a post-COVID era.