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Pharma Legal Handbook All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in…

Pharma Legal Handbook All legal aspects surrounding orphan drugs and rare diseases in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119. 1. What is the definition of Rare…

Pharma Legal Handbook All legal aspects surrounding localization in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119. 1. Are there any rules or regulations requiring and/or encouraging localization…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? Under the Pharmaceutical Law, a product is deemed as generic with respect to the reference product if it has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product,…

Global CSL, Australia’s largest biopharma company, overcame the challenges of the pandemic-related decline in plasma collection and has since racked up wins such as the acquisition of Vifor, the largest in the company’s history, and the FDA approval of its gene therapy for haemophilia B. Newly appointed CEO Paul McKenzie takes…

Greece IFET is a unique institution within Greece that acts as the country’s mechanism for securing access to rare disease therapies not available in the market. The organisation also works to combat drug shortages in the country and played a key role in Greece’s COVID-19 pandemic response as the contracting authority…

Alvion John Bouros of Greek generics start-up Alvion outlines the company’s rapid development since its foundation back in 2014, its product and market selection strategy within Europe, partnerships, business development, and his ambitious goals for the firm’s future.   [We have] confidence that we will soon become one of the leading…

Europe Writing in the special December 2022 edition of DIA’s Global Forum magazine, Eli Lilly’s Mark Mayer, Pfizer’s Nick Sykes and Julie O’Brien, and the EFPIA’s Sini Eskola, Magda Chlebus, and Chloé Garay look at the EU regulatory system’s resourcing challenges and call for long-term multi-stakeholder engagement to help resolve them.…

China Writing in the special December 2022 edition of DIA’s Global Forum magazine – which focuses exclusively on decentralised clinical trials – on behalf of the DIA China Digital Health Community (DHC), Takeda’s Alicia He and Pfizer’s Mia Sun examine the progress made on decentralised and digitalised trials in China.  …

Egypt Bristol Myers Squibb’s Oscar Delgado outlines the firm’s successes in bringing innovative medicines to the Middle East and Africa in recent years, how its strategy plays out in an economically diverse region, why partnerships are of vital importance, and the ways in which BMS is participating in Egypt’s healthcare transformation.…

Egypt While universal health insurance is the talk of the town in Egypt today, private healthcare groups – serving up to 40 percent of the population in both the insurance and out-of-pocket markets – still have an important role to play. This role covers both providing high quality care to their…

UK Bernard Ross, a serial entrepreneur with more than 20 years’ senior experience at private and public board level across multiple industries, looks ahead to 2023 and highlights five key trends to watch in the medtech space. With the COVID-19 pandemic having fast-forwarded the adoption of medical device innovations to solve…