Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…
Europe Rainer Westermann of venture capitalist coalition Life Sciences Acceleration Alliance reviews the potential impact of the EU’s general pharmaceutical legislation on the investment climate for the EU life sciences sector. Building on his insights from last year, Westermann urges stakeholders to seize the opportunity caused by a delay in the…
USA US Congress has highlighted Chinese biotechnology firms, including giants WuXi and BGI, as posing a risk to the country’s national security. PharmaBoardroom takes a look at why the US is now targeting these companies and the potential impact of a proposed US Biosecure Act on US-China biotech ties. Protecting…
Europe The European Federation of Pharmaceutical Industries and Associations (EFPIA) has elected a new president and vice presidents who have set out a key priority for their term: a series of amendments to the proposed European Commission (EC) pharmaceutical legislation reform, which the organisation has warned will further accelerate the loss…
Europe Alexander Natz of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) casts his eye over the potential effects of the upcoming EU Pharmaceutical Legislation for small- and medium-sized enterprises in Europe. Natz feels that Europe is at a crossroads in terms of its positioning as a driver of innovation and calls…
Europe Based on current discussions by the European Commission, launch conditionalities would not account for the distinct nature of small and mid-sized companies, OMPs and ATMPs. EUCOPE’s Alexander Natz breaks down this aspect of the revision of the general pharmaceutical legislation and why it would prove unsustainable for smaller companies and…
Russia Nadezhda Fedotova and Andrey Zelenin of Lidings law firm gives an update on recent amendments to the labeling legislation for medicines in Russia, their potential impact on the Russian pharmaceutical industry, and the numerous uncertainties still remaining. Despite the time moving up to January 1, 2020, it seems impossible…
Pharma Mario Marazziti, President of the Italian XII Social Affairs Commission, discusses new legislation relating to clinical risk, the effects of the 2014 Pact for Health, and the efficiency of Italian healthcare in general. You were recently highly instrumental in the passing of new legislation relating to clinical risk. Could you…
regulation Carlos Chiale, National Administrator of ANMAT, discusses the agency’s latest strategy implementation and its pioneering work in the area of fighting drug falsification. Could you provide a historical overview of ANMAT, its main achievements and current activities today? Since its creation in 1992, ANMAT has performed activities intended for…
generics Chile is aiming to achieve complete bioequivalence of generics by the end of 2014. Chile’s Public Health Institute is leading the bioequivalence testing, aimed at regulating differences between generic and bioequivalent drugs. The recently appointed director of the Public Health Institute, Ricardo Fabrega, echoes the need for drastic change and…
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