Tagged with Regulatory

Canada Luc Boileau, president and CEO of INESSS, the Quebecois National Institute of Excellence in Health and Social Services, the region’s healthcare technology assessment (HTA) body, describes how his organization is adapting to the evolutions taking place in global healthcare and the synergies that exist between the separate Quebecois and Canadian…

Bulgaria Nikolay Petrov, Bulgaria’s minister of health, explains the five cornerstones of the country’s health strategy moving forward and highlights the role of the Ministry in finding common ground between patients, the industry, healthcare professionals, and the National Health Insurance Fund. What are the cornerstones of the Bulgarian health system and…

Bulgaria Assena Stoimenova, member of the management board of the European Medicines Agency (EMA) and executive director of the Bulgarian Drug Agency (BDA), explains the Agency’s evolution under her tenure as well as her commitment to ensuring that the BDA remains predictable, transparent and fair, being fully focused on safeguarding patients…

Tunisia Inès Fradi, general manager of the DPM (Directory of the Pharmacy and Medicine in Tunisia), explains the particularities of the Tunisian healthcare system and the work of the DPM in regulatory affairs as well as its interactions with the other private and public entities. She presents the recent achievements of…

Brazil Lauro Moretto, Emeritus President of the Brazilian Academy of Pharmaceutical Sciences and former Executive Vice-President of Sindusfarma provides insights into the main changes that have impacted Brazil’s pharmaceutical field over the past few years as well as his vision to propel the development of pharmaceutical sciences in the country. What…

Brazil In an exclusive interview, Jarbas Barbosa da Silva, Director-President of the Brazilian Health Regulatory Agency (ANVISA), discusses some of the key specificities of the Brazilian market and highlights some of the main regulatory updates implemented by ANVISA over the past two years, while providing insights into the collaboration opportunities he…

Colombia Marisol Sanchez, executive president of ANDI’s Medical Devices Chamber in Colombia, speaks about the opportunities and challenges in the country’s medtech sector, the industry’s strong ethical code, the key role of the Chamber in supporting its members to navigate the regulatory landscape, as well as the need for a sustainable…

Ukraine Vladimir Sayenko, founding partner, and Anzhela Makhinova, counsel, of the leading Ukrainian law firm Sayenko Kharenko, give an overview on the Ukrainian pharmaceutical industry in 2017 and explain the expansion of the firm into new practices in order to further respond to the needs of its clients. What has changed…

Austria Robert Sauermann, head of the department of pharmaceutical affairs in the Main Association of Austrian Social Security Institutions, which publishes the national code of reimbursement, provides an in-depth look into how drugs are assessed before being placed onto the reimbursement list as well as the challenges faced when negotiating with…

Canada Dr. Gaétan Barrette, Minister of Health and Social Services for Quebec, recaps the ambitious healthcare reforms pertaining to system integration and primary care access he has implemented since assuming position in April 2014, the philosophy driving his reform style, and the advantages that Quebec boasts as a life sciences hub.…

Colombia Luz Stella Gomez, General Manager for the Colombian medical device distributor Gemedco, talks about the positive impact that INVIMA’s regulations have had on the Colombian health sector, Gemedco’s portfolio evolution since General Electric’s acquisition, upcoming partnerships for 2017 and the company’s focus on bringing value to the market. Ms. Gomez,…

USA Janet Lynch Lambert, CEO of the Alliance for Regenerative Medicine (ARM), discusses the association’s aims and membership, the importance of creating a supportive reimbursement environment for regenerative medicine, and the huge and expanding need for education in this critical area. What was the initial inspiration behind setting up the Alliance…