Searching for "process" found 11

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. What are the pricing models, processes and principles for originator drugs? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What are the pricing models, processes and principles for originator drugs? An original drug is defined as a drug approved by Swissmedic as the first drug with a specific active ingredient, including all dosage…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What are the pricing principles and processes in your country? As mentioned above, there are two main markets for medicines in Denmark: the primary healthcare sector (prescription medicines) and the secondary sector (hospitals).…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. What are the pricing models, processes and principles for originator drugs? The main enactment setting out the pricing models and approval procedures for medicines is Ministry of Health’s Order no. 368/2017 approving the Norms…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What are the pricing models, processes and principles for originator drugs? To set the price of originator drugs, CMED uses Health Technology Assessment (“HTA”) to evaluate whether a drug provides an additional therapeutic benefit…

Pharma Legal Handbook 1. What are the pricing models, processes and principles for originator drugs? Originator medicinal products must go through price and reimbursement proceedings (P&R Procedure) where it is decided if they are to be reimbursed or not. If reimbursed, the PVL is also fixed. To determine whether a medicinal product is…

Egypt Three country managers with a recent experience of bringing new products from their company’s global portfolio into Egypt – and with big plans for more launches in coming years – outline how the product launch process has improved and why government stakeholders are more receptive than ever to industry innovations.…

Portugal Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on post-market approval processes and regulations in Portugal. Buy The Pharma Legal Handbook: Market Access & HTA – Portugal here for £359.   What are the pricing principles and processes in your…

Baltics As the Lithuanian market matures, profound shifts have been taking place in the arena of human resources and how drug developers go about identifying, acquiring and retaining the personnel they require for a new age of medical science. “There are a number of emerging trends underway that are forcing companies…

Research NIBRT’s projects director discusses the new ‘Biologic’ center for biologics research, business development, training, and commercializing the organisation’s extensive research capabilities. As Projects Director, you are responsible for driving NIBRT’s growth and development, in terms of both research and bioprocessing training. What’s the most exciting opportunity that NIBRT is currently working on?…

Pharma FDI into Irish pharma has almost exclusively targeted in biologics production over the last few years, largely due to Ireland’s skilled workforce of bioprocessing technicians. NIBRT director Dominic Carolan discusses how the institute supports the Irish biopharma industry through training and recruitment solutions, while pursuing research that may help to…