Tagged with EG

Italy Domenico Mantoan, General Manager of AGENAS, the Italian National Agency for Regional Health Services, discusses the role of the agency in Italy’s decentralised healthcare system, the National Recovery and Resilience Plan’s aim to improve territorial inequalities, and the National Outcomes Program managed by AGENAS on behalf of the Ministry of…

Americas Collaboration, convergence, and other best practices have been at the center of discussions related to the regulatory environment in Latin America and the Caribbean, including DIA’s Latin America Regulatory Conference (LARC) 2022, where voices from global regulators, regional and international organizations, industry, and academia discussed the strategies supporting current practices and…

Asia-Pacific Writing in the June edition of DIA’s Global Forum magazine, Ellen Sem, Fengyun (Vicky) Han and Annetta C. Beauregard from Janssen Pharmaceutical Companies of Johnson & Johnson, outline the real-world data (RWD) and real-world evidence (RWE) regulatory landscape in Asia Pacific.  Real-world data (RWD) and real-world evidence (RWE) have played an…

Pharma Legal Handbook A brief overview of the situation regarding regulatory, pricing and reimbursement in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction…

Pharma Legal Handbook Preclinical and clinical trial requirements in Uruguay –  a legal guide. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as…

Pharma Legal Handbook All about marketing, manufacturing, packaging & labeling and advertising in Uruguayan pharma. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs,…

Pharma Legal Handbook The key facts about traditional medicines and OTC products in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative…

Pharma Legal Handbook The legal framework for product liability in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Product liability could be attributed…

Pharma Legal Handbook An insight into patents and trademarks in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? For trademarks, the…

Pharma Legal Handbook Key legal info on regulatory reforms in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? Currently, a…

Pharma Legal Handbook Important legal questions related to cannabinoid drugs, medicinal cannabis and opioid drugs in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country?…

Pharma Legal Handbook An intro to the legal situation for orphan drugs and rare diseases in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases…