Tagged with AI

Pharma Legal Handbook All about marketing, manufacturing, packaging & labeling, advertising in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   1. What is the authorization process for the marketing…

Pharma Legal Handbook Preclinical & clinical trial requirements in Spain – a comprehensive legal overview. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for GBP 119.   1. Are clinical trials required to be…

Pharma Legal Handbook Key legal info on regulatory, pricing and reimbursement in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain.   The guide is available to purchase here for GBP 119.   1. What are the regulatory…

Asia-Pacific Through compassionate use programs patients suffering from critical, life-threatening conditions can access potential life-saving therapeutic options which have not been formally approved by the responsible health authority in an ethical and regulated way. ChongXiang Tan, Fengyun (Vicky) Han and Annetta C. Beauregard of Janssen Pharmaceutical Companies of Johnson & Johnson…

Spain Over the course of 2022, PharmaBoardroom spoke to over 50 leading stakeholders in the Spanish healthcare and life sciences, from top Spanish scientists to regional ministers of health, multinational affiliate managers, and the heads of some of the country’s leading domestic firms. These interviewees’ insights are catalogued in the downloadable…

Italy Digitalisation has become a buzz word in in the global life sciences sector. In Italy, digital transformation has taken on special significance as one of the principal goals encompassed in the country’s National Recovery and Resilience Plan and a priority within its healthcare modernisation plans.   Novel solutions came out…

Italy The Italian system requires drug companies to go through approvals at a national level with the Italian Medicines Agency (AIFA), only to then confront the country’s 21 regional authorities who independently manage the budget for territorial pharmaceutical expenditure and evaluate regional access. According to many industry stakeholders, this lengthy process…

Bahrain Dr Mariam Al Jalahma, CEO of the Kingdom of Bahrain’s National Health Regulatory Authority (NHRA) remarks on the healthcare transformation that led to the creation of the NHRA and explains the Bahraini regulatory body’s comprehensive responsibilities that range from the registration and pricing of essential medicines to the approval of…

Hong Kong After a record year of new biotech listings in 2021, the Hong Kong Stock Exchange (HKEX) has seen a significant drop-off in the first eight months of 2022. The exchange went from 20 new listings last year to only four this year, with just three full months of 2022 remaining…

Italy Tiziana Mele, managing director of Lundbeck Italia, explains the impact of COVID on mental health care from the perspective of a company dedicated to brain health, outlines the Italian operation that includes both  commercial and production capacities and shares Lundbeck’s support of independent clinical trials in the country. The pandemic…

Middle East & Africa Apart from a maturing regulatory environment and the expansion of healthcare coverage across the region, a number of other factors are contributing to the evolution of the MEA pharma market. Results from the second wave of a PhRMA-commisioned IQVIA market access study covering Saudi Arabia (KSA), UAE, Kuwait, Lebanon, Jordan,…

Italy Guerbet’s Alessandro Bocci – General Manager Italy & Iberia – describes the nearly 100-year-old company’s firm position in the field of contrast media for radiology and its plans for developing a portfolio in artificial intelligence (AI). In addition, he outlines how the Italy, Spain and Portugal cluster made its way…