Tagged with Regulatory Reform

Pharma Deputy Minister of Health for Pharmaceutical Affairs Tarek Salman discusses how pharmaceutical regulation in Egypt is taking a leap forward, with the introduction of new legislation with parallel registration process that will bring approval timelines under 21 months, and the imminent establishment of the Egyptian Drug Authority, which will merge…

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 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 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,…

pharma The Vice President of Health and Medicine at Pierre and Marie Curie University (UPMC) and Director of the University’s Institute of Oncology reveals how the French social security system needs to look at how to evaluate real needs, why the patient has to become more involved in the decisionmaking process,…