Tagged with EG

Pharma Legal Handbook All legal aspects surrounding preclinical and clinical trial requirements in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. Are clinical trials required to be conducted locally as a condition…

Pharma Legal Handbook An insight into regulatory, pricing and reimbursement in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical…

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…

Asia-Pacific Writing in the April edition of DIA’s Global Forum magazine, Dhiraj Behl, Janine Jamieson, and Harikesh Kalonia highlight some of the regulatory challenges for drug-device combination products in APAC, including the lack of an international body dedicated to harmonisation in this field.   In the current innovation era and in the wake…

LatAm Writing in the April edition of DIA’s Global Forum magazine, Maria Cristina Mota Pina of Abbvie on behalf of FIFARMA Regulatory & Biologics Working Group highlights the significance of regulatory reliance between regulators in the LatAm and Caribbean region and proposes how it can be strengthened.   Regulatory reliance is…

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…

Switzerland Dr Miro Venturi of Swiss injectable anaesthetics and analgesics specialist Sintetica outlines his career journey, why personalised medicine is about taking a holistic view across the entire patient journey, and the growth strategy he has set out for the company.   Since the largest pharma companies are often not directly…

Switzerland Nerum Pharmaceuticals, a Switzerland-based start-up, is supplying high-grade cannabis products to nine countries around the world. CEO and Co-Founder Alex Pombo highlights how the company leverages their unique Swiss-Colombia connection, the dynamics shaping the cannabis product industry, and Nerum’s role supplying ingredients to businesses in the pharmaceutical, cosmetic and food…

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…