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EMA: Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with revision 1 of module III on pharmacovigilance inspections and of module VI on the management and reporting of adverse reactions reports

25.09.2014
This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product or Population-Specific Considerations. ...

EMA: Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products

25.09.2014
This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and chapter 3 of Regulation (EC) No726/2004 [REG], which are applicable to competent ...

EMA: Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections

25.09.2014
This Module contains guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU and outlines the role of the different parties in volved. General ...

FDA: Q4B - Annex 6 Uniformity of Dosage Units General Chapte

25.09.2014
This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their ...

GMP: Complaints and Recalls: new EU-GMP Chapter 8 published

25.09.2014
The European Commission has published the final Chapter 8 of the EU Guidelines for GMP (Complaints, Quality Defects and Product Recalls). The chapter has been revised completely. ...

EMA: New legislation for veterinary medicines

11.09.2014
European Medicines Agency welcomes European Commission proposal to increase availability of medicines across Europe. New rules have been proposed by the European Commission to improve the health ...

EMA: Note for guidance on the format and content of the annual report on the state of development of an orphan medicinal product

11.09.2014
Article 5 (10) of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products requires sponsors to submit annual reports on the state ...

GMP: Current FDA\'s Warning Letters on IT Topics - Part 2: Finished Medicinal Products and APIs

11.09.2014
In a first stage of escalation - when serious GMP deviations are identified during inspections, or in case of insufficient corrective measures - the FDA issues a Warning Letter to the companies ...

GMP: Still a GMP problem? Or already a criminal act? Do we need more stringent measures and enforcement in certain situations?

11.09.2014
When GMP issues are discussed, different interpretations are possible. Sometimes, the implementation of GMP regulations and expectations can be a challenge. However, everyone involved should do ...

EMA: Regulatory information - European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines

04.09.2014
The European Medicines Agency (EMA) has updated its procedural guidance to ensure that marketing-authorisation holders are prepared for the submission of periodic safety update reports (PSURs) for ...

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