The training has been designed to offer, with a distinctly practical approach, a useful opportunity to deepen the key points of Annex 1, providing learners with advice and examples on the correct way to interpret and implement the main points of the standard. It will take place on May 11 in Florence.

^{March 21, 2023}

Pharma D&S will attend Dia Europe 2023, a congress with a comprehensive program that covers a wide range of tracks from Clinical Trials and Pharmacovigilance to Value and Access, Regulatory Operations, and much more.

^{March 9, 2023}

The European Pharmacovigilance Congress, organized by Pharma Education Center, is recognized as one of the most important and appreciated conference on Pharmacovigilance. Last year, delegates from more than 50 countries worldwide have joined the two days of virtual event followed by the day in presence in Milan. Growing year after year, the European Pharmacovigilance Congress gathers professionals at all career levels, including key decision makers (e.g. Directors, VPs and Executives) interested in the always evolving pharmacovigilance world and its new trends, and willing to implement more efficient and effective strategies and tools for their departments.

^{March 7, 2023}

Pharma D&S will be sponsor of  “Giornate di Studio AFI”, an event organized by Associazione Farmaceutici Industria (AFI) on March 1 and 2 at Centro Congressi in Rome

^{February 23,2023}

The Italian Medicines Agency AIFA provides some clarifications to all pharmaceutical companies regarding the submission of changes to the AIC. These clarifications concern the changes presented according to the national, mutual recognition/decentralized (MR/DC) procedure pursuant to EC Regulation No. 712/2012 and in line with the new “classification guidelines” of the European Commission dated 16/05/2013. The objective is to favor the correct presentation by companies of applications concerning changes to the AIC. You can find enclosed the update of the Explanatory Note of the AIFA Resolution of 25 August 2011.
_{August 4, 2021}

The European Medicines Agency issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission GMP guidelines and other EU legislation. In general, these responsibilities range from responsibilities that relate to outsourcing and technical agreements, to ones that require the MAH to perform certain specific tasks. These responsibilities are spread over the various chapters and annexes of the GMP Guide, and are quite numerous.
_{August 2, 2021}

The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications. This guideline focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy of a medicinal product and outlines where this information should be placed in the Common Technical Document. The guideline should be read in conjunction with the Q&A on the implementation of the MDR.
_{July 27, 2021}

Medical Device Coordination Group Document (MDCG) published a guidance note integration providing recommendations on how the UDI can be integrated within a medical device organisation’s quality management system in order to meet requirements of the Medical Device Regulation (MDR) and in Vitro Diagnostics Regulation (IVDR).
_{July 20, 2021}