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EIPG Newsletter

EMA opened a consultation on the use of patient registries for regulatory purposes

Patient registries might provide a great amount of data useful for regulatory purposes. The European Medicines Agency has published a Discussion paper and a consultation is open up to 30 June 2019 to better evaluate how to exploit this opportunity

How to manage the data integrity risks

The management of data integrity risks is fundamental to ensure data are correctly handled during the entire process of pharmaceutical manufacturing. An effort that is facing the increasing complexity of IT systems

From Finland: The pharmaceutical industry expects the future government to invest in health and...

Pharma Industry Finland calls the future government to invest in health and research to increase the competitiveness of the country. Flexible financing models, a single HTA body and an improved environment to support clinical R&D are among the suggestion of the local representatives of the pharmaceutical industry

Monthly update from EIPG: J’accuse? No, I believe!

EIPG's president Claude Farrugia comments on recent hot topics that might impact the pharmaceutical sector and gives his suggestion to encourage collaboration among all stakeholders. EIPG's member are called to express their opinion on the monthly newsletter. While the set up of the Advisory Group on the Education of Industrial Pharmacists continues, EIPG's representatives contributed to the MOGLYNET Summer School with lessons on the application of GMPs and GDPs

Hard Brexit, soft Brexit, no Brexit?

After the approval of the withdrawal agreement by the European Council, in UK the Parliament's vote has been postponed and the chaos is prevailing. All possibilities are currently open for the Brexit, just three months before 29 March 2019. A summary of latest events.

From the EU: Quality of healthcare in the EU

The quality of healthcare in the EU is a central debate going on at the European institutions, in order to identify how to reach a more equal and sustainable situation of the healthcare systems in use by different countries

ISO Excellence Award to five EMA’s experts for their achievements in the development of...

ISO IDMP standards are at the basis of SPOR systems and are used to unambiguously identify medicinal products and all substances and facilities used for their manufacturing using uniformed definitions. The so obtained master data can be used for multiple regulatory procedures in different geographical areas

The peril road of the SPC manufacturing waiver

Discussions on the SPC manufacturing waiver are ongoing at the European institutions. Lobbying is also occurring to protect the diverging interests of originators and genericists. The ENVI and INTA Committees of the European Parliament published their opinions on the issue

The use of real world data for R&D of pharmaceuticals

EMA's director general Guido Rasi is among the authors of a paper published in Clinical Pharmacology and Therapeutics, discussing from a regulatory perspective the use of real world data to boost pharmaceutical development

Monthly update from EIPG: An Advisory Group for the education of industrial pharmacists

EIPG is planning the launch of an Advisory Group for the education of industrial pharmacists, in order to better support competences needed by the industry. Representatives of the association participated to the EMA meeting on shortages of medicines. EIPG is also collecting opinions on ICH Q12 draft guideline to be submitted to the open consultation. A webinar on data integrity is also planned for 11th December