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ATMP in the EU - Regulatory Roadmap

13.10.2021
Advanced Therapy Medicinal Products (ATMPs) represent a fast-growing field of therapies consisting of cellular or genetic components that revolutionize the treatment approach of many previously ...

Czas na staż – praktyki studenckie

05.10.2021
PRAKTYKI studenckie 2021 We wrześniu 2021 r. zakończyliśmy letnią edycję praktyk studenckich dla osób chcących zdobyć pierwsze doświadczenie w sektorze usług ...

Pharmacovigilance inspections - key points that you should know

14.09.2021
Pharmaceutical industry, and more particularly pharmacovigilance, is strictly controlled field in terms of having many regulations and laws established by health authorities with rigid timelines ...

How CMDh helps Marketing Authorisation Holders to facilitate regulatory procedures during the COVID-19 crisis?

17.08.2021
The SARS-CoV-2 virus pandemic has undoubtedly affected various areas of our lives, not only our private lives and interpersonal contacts, but it has also firmly affected the areas of lives ...

Registration of medicinal products – how to choose the right type of application?

02.07.2021
Registration of medicinal products – how to choose the right type of application? Anyone, who has even a little experience with pharmaceutical industry, probably knows that the ...

Why is pharmacovigilance needed in your company?

30.06.2021
If you run a pharmaceutical company with the investigational or authorised medicinal products you must have heard about pharmacovigilance (PV). As legal obligation is imposed on any Marketing ...

Are nitrosamines still a concern for a drug product?

09.06.2021
In June 2018 it was recognized that some active substances used in manufacturing of medicinal product contained undesired levels of potentially carcinogenic nitrosamine impurities (e.g. NDMA, ...

EMA: Concept paper for the revision of the note for guidance on the use of adjuvanted veterinary vaccines

29.09.2016
The Immunologicals Working Party (IWP) recommends revisiting the contents and replacing the note for guidance on the use of adjuvanted veterinary vaccines with a new guideline, to take into ...

FDA: Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease

29.09.2016
This guidance provides a qualified context of use (COU) for the biomarker plasma fibrinogen, in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high ...

FDA: Self-Identification of Generic Drug Facilities, Sites, and Organizations

29.09.2016
This guidance is intended to assist human generic drug facilities, sites, and organizations by describing how to comply with the self-identification requirement contained in the Generic Drug User ...

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