Tagged with Regulatory

Pharma Giulio Volpe, Managing Director of Lundbeck’s Italian API’s production plant, discusses what is leading multinational companies to relocate their production to Italy, the value the Italian plant can offer the Lundbeck group and the future of API production in Italy. Could you start off with a brief overview of the…

Pharma Abbvie has taking a leading role in the Egyptian pharmaceutical industry by bringing their new all-oral hepatitis C treatment to Egypt, the country with the highest prevalence of the disease in the world, making the company a major stakeholder in the country’s highest priority healthcare issue. How would you assess…

Pharma The Italian Medicines Agency, AIFA, sits at a crossroads. Its Director-General Prof. Luca Pani discusses the apparent contradiction in the agency’s mission at a time of constricting budgets and expensive medicines, how the agency’s role is evolving in response and in which ways the agency can collaborate with the industry.…

pharma With almost thirty years of experience in the life sciences sector, local Dutch consultancy firm Baggerman Farma Consult offers a wide portfolio of services to its clients in the pharmaceutical and life sciences industry to meet all of their regulatory needs. Kees Baggerman, CEO and founder, highlights the new Gateway…

Pharma Bayer broke into the top ten multinationals in Egypt this year, after achieving a remarkable 110 percent growth over the last two years. General manager Hatem Safei discusses the developments that drove this strong expansion, and the overall potential he sees in the healthcare market going forward. What are the…

Romania No one can accuse the Romanian government of being lethargic when it comes to healthcare reform. After an unprecedented seven years of zero new molecules being admitted to the state reimbursement list, the pharma industry has suddenly been subjected to a whirlwind of radical refashioning and legislatory upheaval. “The industry…

pharma The minister of health reveals how for the first time in the country´s history the healthcare sector is following a clear roadmap with the National Development Plan, a vision for where the country should be in 2030, how the National Health Initiative will mean a total reconstruction of the healthcare…

Pharma “Egypt: the golden gate to Africa” – The head of the export council of medical industries reviews the remaining obstacles on the way to double the value of Egyptian exports until 2018, and explains his vision of an African Union with Egypt positioned at its center. Could you please give…

Pharma Ansie Savrda of ERS (pty) ltd, highlights the important role that ERS plays in helping pharmaceutical companies to efficiently navigate South Africa and Africa’s regulatory environment through the company’s broad portfolio of regulatory advisory services. As an introduction, what were your initial aspirations starting ERS? There is a continuous progression in the market…

pharma The founder and managing director of LT Clinical Research, one of the first wholly black-owned South African CRO, reveals how South Africa is a very conducive environment for CROs, with a diverse patient population, a well-established regulatory framework and a currency that compares well to other African currencies; why the…

Pharma Eduardo Negrón-Navas, attorney-at-law, for the Puerto Rican law firm Fiddler, González & Rodríguez, discusses the firm’s long-standing service to the pharmaceutical industry and the need for both government and industry to reinvent a business model better defined for the new realities of the 21st century. What is your evaluation of…

Pharma The managing director of Trinity Pharma, Gaby Simaan (Jnr) depicts Trinity’s evolution from a regulatory consultancy into a fully commercialized pharmaceutical company, and how their unique position in the private label space has allowed the company to significantly expand its pipeline of products and presence in the market. To begin,…