Tagged with P

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for GDP 99.   1. What are the regulatory authorities with…

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. What are the regulatory…

Pharma Legal Handbook A brief overview of the situation regarding preclinical and clinical trial requirements in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. Are clinical trials…

Pharma Legal Handbook All about marketing, manufacturing, packaging & labeling, advertising in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. What is the authorization process for the…

Pharma Legal Handbook An insight into traditional medicines and OTC products in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional,…

Pharma Legal Handbook The low-down on the situation regarding product liability in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. What types of liability are recognized in…

Pharma Legal Handbook Want to know more about patents & trademarks in Ireland? Read on! Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. What are the basic requirements…

Pharma Legal Handbook Key legal info on regulatory reform in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for GBP 99.   1. Are there proposals for reform or significant change to…

Spain mAbxience’s CEO Emmanuelle Lepine highlights the company’s international expansion into highly regulated markets, new investment into its Spanish manufacturing facility, and its partnership with AstraZeneca on COVID-19 vaccine manufacturing in Argentina. As representatives from the US FDA carried out a Good Clinical Practice inspection in an adjacent office, Lepine outlined…

Global 2021 saw PharmaBoardroom’s network of executives and experts weighing in on some of the most pressing issues facing our industry today. See below for five of the most thought-provoking pieces, ranging from patient engagement to access solutions, infrastructure building, biomarkers, and sustainability.   A ‘Bold Vision’ of Patient Engagement The…

Saudi Arabia Waleed Mohammed Al-Shaqha PharD PhD outlines the important role that API manufacturer CAD plays within Saudi Arabia, the importance of local manufacturing within the supply chain more broadly, and how Vision 2030 is reshaping the country’s industry paradigm.   Today, international companies can see the value and the benefit of…

Europe Writing in the December edition of DIA’s Global Forum magazine, Thomas Kühler updates his August piece on the progress towards a unified HTA system in Europe and the objectives of the recently launched EUnetHTA 21 initiative.   Global Forum recently published a piece on Health Technology Assessment (HTA) in the EU and how a regulation…