Switzerland Biogen Switzerland’s Dr med Katharina Gasser outlines how her affiliate navigated the COVID-19 pandemic from an organisational and communication perspective, the increasing importance being given to mental health by the Swiss government, and the reimbursement and market challenges facing Biogen in 2021 and beyond. 2020 saw a lot of…
Pharma Legal Handbook An insight into medical devices in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119. 1. Who are the regulatory authorities governing medical devices in your…
Russia The latest Russia Pharma News, including Biocad’s ramping up of Sputnik V COVID-19 vaccine manufacturing, Geropharm’s deal to produce insulin in Venezuela, the bypassing of Gilead’s Remdesivir IP, and the Russian government’s decision to delay approvals of Chinese vaccines in favor of local shots. Russian Biocad plans to produce…
Pharma Legal Handbook Key legal info on regulatory, pricing and reimbursement in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The following…
Pharma Legal Handbook The ins and outs of preclinical & clinical trial requirements: Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. Are clinical trials required to be conducted locally as a condition (stated or…
Pharma Legal Handbook Marketing, manufacturing, packaging & labeling, advertising in Bulgaria – a comprehensive legal overview. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What is the authorisation process for the marketing of new drugs, biologics, medical devices, over-the-counter medications,…
Pharma Legal Handbook The key facts about traditional medicines and OTC products in Bulgarian Pharma. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines…
Pharma Legal Handbook All legal aspects surrounding product liability in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What types of liability are recognized in your jurisdiction? There are three types of liability recognised…
Pharma Legal Handbook A brief overview of the situation regarding patents and trademarks in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What are the basic requirements to obtain patent and trademark protection? A)…
Pharma Legal Handbook The low-down on the situation regarding regulatory reforms in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? The topic…
Pharma Legal Handbook The key facts about the cannabinoids drugs in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Pursuant to the Narcotic Substances and…
Pharma Legal Handbook Keen to learn more about orphan drugs & rare diseases in Bulgaria? Read on! Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? Under…
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