Newsletter

The Pact for Research and Innovation in Europe
17 September 2021 | Giuliana Miglierini

The proposal adopted by the EU Commission details the main features and approach to the realisation of the new European Research Area and calls member states to voluntary increase the level of R&I investments up to the 3% target planned for 2030.
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The opportunity for repurposing of oncology medicines
10 September 2021 | Giuliana Miglierini

Non-commercial repurposing of oncology medicines may offer interesting opportunities for treatment of rare cancers, but many issues still have to be solved. The topic has been debated during the last Joint meeting of EU Directors for Pharmaceutical Policy & Pharmaceutical Committee.
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A golden era for UK’s life sciences and a new Code of practice for its pharmaceutical industry
3 September 2021 | Giuliana Miglierini

The launch of the new Life Science Vision by the UK’s government has corresponded to a successful moment in the raising of investments in the biotech sector and to the publication of the new Code of Practice for the promotional activities of prescription medicines.
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Webinar: PBPK Modelling and Simulation
27 August 2021 | EIPG

Over the last 20 years Physiologically–Based Pharmacokinetic(PBPK) Modelling and Simulation has developed and is now used extensively within Discovery and Development in the Pharmaceutical Industry.EIPG’s and PIER’s next webinar,to be held on 21st October 2021.
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Artificial intelligence in medicine regulation
20 August 2021 | Giorgos Panoutsopoulos

The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in a report published on 16 August 2021.
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Draft guidelines, open for consultation
13 August 2021 | EIPG

ICH guideline Q13 on continuous manufacturing of drug substances and drug products.
Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells.
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The Swiss interoperable national eHealth infrastructure
6 August 2021 | Giuliana Miglierini

The new strategy will be adopted by all Swiss university hospitals and academic institutions. It provides a common semantic framework to be used in synergy with the existing tools to meet the needs of both patients and the healthcare system.
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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.
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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.
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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.
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EMA publishes Q&A document about Parallel Distribution
9 July 2021 | EIPG

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. .
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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.
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