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
3d 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
3w 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
1M 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
1M 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
2M 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
2M 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
Regulatory Pharma Net Blog
3M ago
The regulation detailing the organization and functioning of the Scientific-Economic Commission of Pharmaceuticals (CSE) of the Italian Medicines Agency (AIFA)...
L'articolo The regulation of the Scientific-Economic Commission of Pharmaceuticals of AIFA sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
3M ago
The transition of clinical trial applications from the Directive 2001/20/EC (CTD) to the Regulation EU No 536/2014 (CTR), facilitated by...
L'articolo Transitioning to CTIS: Key Steps and Documentation Required sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
3M ago
According to GVP (Good Pharmacovigilance Practices) Module VI, MAHs are required to conduct actively global literature searches at least once...
L'articolo Clarifying “Day Zero” in Medical Literature Reporting: focus on paper journals. sembra essere il primo su - RPN ..read more
Regulatory Pharma Net Blog
4M ago
The Italian Medicines Agency (AIFA) recently introduced a guideline for Notified Bodies planning to submit a consultation for ancillary...
L'articolo AIFA’s New Guidelines for Class III Medical Devices with Ancillary Medicinal Substances sembra essere il primo su - RPN ..read more