Tagged with Regulation

Canada Susanne Picard, founder and president at SPharm, speaks about how her passion for regulatory affairs led her to found her own consultancy in 1997 and how the company can look back at an impressive track record of success over the last 21 years. Here, she outlines key priorities to further…

Estonia Kristin Raudsepp, director general of Estonia’s drug regulator – the State Agency of Medicines – discusses her organization’s mandate, current priorities, and reactiveness to the pervading trends in international regulation. Can you introduce the State Agency of Medicines of Estonia and its mandate to our international readers? “Despite of the…

Switzerland With two billion people globally – predominantly in low and middle-income countries – having little or no access to medicine, a select group of service providers have emerged to try and further dialogue between pharmaceutical companies, regulators, healthcare professionals and patients on the issue of expanding access to medicines. At…

Brazil Leandro Pinheiro Safatle, executive secretary of the Brazilian Drug Market Regulation Chamber (CMED) explains why pharmaceuticals was the only sector to have resisted the country’s recent recession, the role that CMED has played in stabilizing the price evolution of medicines in Brazil, and the importance of increasing the regulatory framework’s…

Canada Colette Rivet, executive director of the Cannabis Canada Association, leading Canadian licensed medical cannabis producers, talks regulatory challenges, upcoming opportunities, export ambitions and collaboration with the provincial and federal government in light of the upcoming legalization of cannabis for adult use in Canada. Colette, can you introduce the Cannabis Canada…

Japan Number of consultations for drugs in Japan by category in 2016. Oncology drugs leads the way, followed by gastrointestinal drugs and respiratory tract drugs. The launch of new medicines for major non-communicable diseases in Japan from 2004-2016 in terms of both applications and approvals. Regenerative medicine product approvals in Japan…

Japan Dr. Tatsuya Kondo is chief executive of Japan’s regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA). Since taking the role in 2008, Dr. Kondo, a qualified neurosurgeon with wide-ranging experience in R&D activities, has been responsible for all the operations of PMDA, including relief for adverse health effects of…

Austria Maria Seriakov, CEO and founder of M bioserviceS, a young Austrian company dealing globally that specialises in logistics, regulatory affairs and quality control of biologics, discusses the challenges of navigating differing regulations across the globe as well as the how a hands-on approach ensures a product’s high quality. Furthermore, she…

Ukraine Tetyana Dumenko, director of the State Expert Center (SEC) of the Ministry of Health of Ukraine, the regulatory agency responsible for product registration, pre-clinical studies and clinical trials approval and pharmacovigilance, provides insights into some of her initial achievements since taking the position and her main strategic priorities to further…

Colombia In explaining the role of the Colombia National Food and Drug Surveillance Institute (INVIMA) and its impact on the regulatory landscape of the healthcare sector, Javier Guzman, Executive Director, centres the discussion on four key pillars: institutional strengthening, efficiency, transparency and competitiveness. He speaks about his main priorities, the Colombian…

Mexico Luisa Gutierrez, CEO at Medisi, explains the importance of helping get fast registration for high quality medtech products registrations and explains Medisi’s integral solutions for both the regulation and distribution of medical devices. Ms. Gutierrez you have quite an unusual professional profile. What triggered you to start your entrepreneurial journey…

Mexico Representatives of Olivares, one of the leading law firms in Mexico, explain the evolving status of cannabis and narcotics for medicinal use in the country. A new Bill authorizing the use of cannabis for medical treatments was passed by the Senate in December 2016, but there is still a long…