Regulatory Pharma Net Blog
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Anita Falezza founded Regulatory Pharma Net s.r.l. in 1999, after having held various positions in the pharmaceutical industry since 1989, such as Regulatory Affairs Director, International Regulatory Affairs Manager, Study Director. Her activities are focused in consulting and strategic coordination of Drug Development and Regulatory Affairs projects in Europe.
Regulatory Pharma Net Blog
2w ago
The European Medicines Agency (EMA) has launched a groundbreaking pilot program designed to enhance the development and regulatory support for...
L'articolo Medical Devices – EMA Launches Pilot Program to Support Orphan Devices sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
3w ago
The Italian Medicines Agency (AIFA) has published a comprehensive update to the guidelines for the classification and conduct of observational...
L'articolo Updated Guidelines for the Classification and Conduct of Observational Studies in Italy sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
1M ago
The European Medicines Agency (EMA) has officially announced that starting from 1st January 2025, the current fee regulation (2024/568) will...
L'articolo EMA – New Fee Regulation (NFR) sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
1M ago
Introduction to HTA Regulation The Health Technology Assessment (HTA) Regulation (2021/2282) represents a significant milestone towards a unified approach in...
L'articolo Understanding the European HTA Regulation sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
2M ago
The Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two pilot projects aimed at improving the quality...
L'articolo ACT EU: Launch of Two New Pilot Projects for Scientific Advice and Clinical Trials in Europe sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
2M ago
The Certificate of Pharmaceutical Product (CPP) is a document issued by a country’s regulatory authority at the request of a...
L'articolo Certificate of Pharmaceutical Product as strategic plan for Extra – EU market: how to request it to AIFA. sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
3M ago
Over the past few years, the use of Artificial Intelligence (AI) in pharmaceutical industry is rapidly expanding. AI is a...
L'articolo The Impact of AI on Pharmaceutical Regulatory Processes sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
3M ago
Legacy devices are those that were approved under the previous MDD but are still in use or available on the...
L'articolo Italian Medical Devices Database: Important Updates for Legacy Devices sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
4M ago
The transparency of transfers of value declared by pharmaceutical companies is crucial for maintaining trust and integrity within the healthcare...
L'articolo Transparency in Healthcare domain: Transfers of value sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
4M ago
The European Medicines Agency (EMA) has recently published a significant update to its guideline on Environmental Risk Assessment (ERA) for...
L'articolo EMA’S NEW GUIDELINES ON ENVIRONMENTAL RISK ASSESSMENT FOR HUMAN MEDICINAL PRODUCTS sembra essere il primo su - RPN ..read more