Pharma Legal Handbook All about marketing, manufacturing, packaging & labeling, advertising in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119. 1. What is the authorization process for the marketing of new drugs,…
Pharma Legal Handbook Key legal info on preclinical and clinical trial requirements in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119. 1. Are clinical trials required to be conducted locally…
Pharma Legal Handbook Regulatory, pricing and reimbursement overview in Italy – a legal guide. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119. 1. What are the regulatory authorities with jurisdiction over…
Global Fortune’s new 50 Most Powerful Women in Business list features four representatives of Big Pharma, as well as a further four from powerful US health insurance corporations. The annual ranking is based on five criteria: the size and importance of a leader’s business in the global economy, the health…
Italy The electoral victory of the centre-right coalition in Italy should see far-right firebrand Giorgia Meloni replace former European Central Bank President Mario Draghi as Prime Minister at the end of October 2022, becoming the first woman to ever hold the role. This spirit of change seems also to have permeated…
Egypt Internationally renowned healthcare quality and safety expert Dr Ashraf Ismail explains the concept behind the Egyptian General Authority for Healthcare Accreditation and Regulation (GAHAR), its work in setting and implementing standards as well as accrediting healthcare institutions in Egypt, and his hopes for the country’s transformational rollout of universal health…
Italy Digitalisation has become a buzz word in in the global life sciences sector. In Italy, digital transformation has taken on special significance as one of the principal goals encompassed in the country’s National Recovery and Resilience Plan and a priority within its healthcare modernisation plans. Novel solutions came out…
Italy The Italian system requires drug companies to go through approvals at a national level with the Italian Medicines Agency (AIFA), only to then confront the country’s 21 regional authorities who independently manage the budget for territorial pharmaceutical expenditure and evaluate regional access. According to many industry stakeholders, this lengthy process…
Italy Historically, SIFI has been a modest local player focused on ophthalmic products, but in recent years the company has set some ambitious goals for itself—becoming a leading force in European ophthalmic markets, breaking into orphan drugs and adding value in the glaucoma field—and is now seeing its ambitions become a…
Italy Seasoned executive Pierluigi Antonelli went from a career in big pharma to Angelini Pharma, a midsized Italian company that has been undergoing major transformation. He shares the motivation behind the move and the main components of the company’s transformational journey. Rather than continue on the perhaps easier path he…
Italy Collectively representing almost 400 companies operating in Italy, Farmindustria, Egualia (formerly Assogenerici) and Assobiotec respectively promote the interests of innovative pharmaceutical companies—both foreign and Italian-owned— the generics, biosimilars and value-added medicines sector, and biotech. Massimo Scaccabarozzi, former President of Farmindustria; Michele Uda, director general of Egualia, and Leonardo Vingiani, managing…
Italy As the European Union’s largest beneficiary of the Next Generation EU (NGEU) package, aimed at boosting the EU’s economy following the COVID-19 pandemic, Italy will receive some EUR 235 billion in grants and loans over the lifetime of its National Recovery and Resilience Plan (NRRP). With respect to healthcare, the…
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