Tagged with EG

Pharma Legal Handbook What types of liability are recognized in your jurisdiction? The following types of liability are recognized under Vietnamese laws: disciplinary liability, administrative liability, civil liability and criminal liability.   How do these types of liabilities apply to the manufacturers of medicines and devices? Provisions on product liability can be found…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? PATENT To qualify for patent protection, an invention must meet the following basic conditions: Be globally novel; Involve an inventive step; and Have its subject matter capable of industrial application. TRADEMARK To be eligible for protection as a…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Law on Medical Examination and Treatment The draft version of an amended Law on Medical Examination and Treatment was submitted to the National Assembly in May 2022 for discussion. Once adopted, the new law will repeal the…

Pharma Legal Handbook   What is the definition of Rare Diseases in your country? There are no legal documents in Vietnam providing a definition of “rare diseases.”   Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?) An orphan drug is a drug…

Switzerland Dennis Engelke, General Manager for Switzerland and Austria at Jazz Pharmaceuticals, discusses his career trajectory and the company’s growth in these markets. He highlights Jazz’s commitment to patient access and innovation, especially following the 2021 acquisition of GW Pharmaceuticals, which has enabled the company to enter the epilepsy space. Engelke…

Mexico Rogerio Peso outlines how Viatris leverages collaborations to address critical healthcare needs in Mexico, combining its strengths with other stakeholders to improve patient outcomes. With a mission to offer high-quality, affordable medicines, Peso also points out how Viatris aligns its portfolio with the healthcare needs of Latin America, addressing gaps…

Singapore Writing in the November 2024 edition of DIA’s Global Forum magazine, Johnson & Johnson’s Sandy Chan looks at the fast-evolving regulatory framework for medicines in the dynamic Asia-Pacific region.   Asia Pacific (AP) is an immensely diverse and dynamic region with varying regulatory capabilities and capacities; consequently, AP regulators and…

Mexico With the naming of Armida Zuñiga as head of the country’s regulatory body COFEPRIS, new Mexican president Claudia Sheinbaum has concluded the new government’s healthcare appointments and begun advancing her agenda by tackling Mexico’s widespread medicine shortages.   New Regulatory Lead By the time Claudia Sheinbaum was sworn in as…

Switzerland Michael Kubischik shares his career journey and Sanofi’s strategic focus in Switzerland. He highlights Sanofi’s dedication to become the world´s leading immunology company, supported by initiatives like AI integration and efficient regulatory processes to improve patient access, as well as the benefits of working for a company with such a…

Mexico Emily Morris, head of Sanofi in Latin America discusses the company’s transformative journey under the 2019-initated ‘Play to Win’ strategy. With an emphasis on optimizing their portfolio and prioritizing immunoscience, she highlights Sanofi’s commitment to leveraging AI to enhance patient access to innovative therapies. Morris also delves into the importance…

Mexico Monica Palomanes, General Manager of Roche Mexico, discusses her journey within the company and the shift from traditional sales to a collaborative approach with Patient Journey Partners. She addresses challenges in access and diagnosis within Mexico’s fragmented healthcare system, while recognising the country’s potential for clinical research due to the…

Switzerland Georg Pirmin Meyer, SVP and Head of International at Blueprint Medicines, shares insights into the company’s journey from a promising startup to a fast-scaling biotech leader focused on allergy/inflammation and haematology/oncology. Meyer discusses Blueprint’s innovative approach to international expansion, patient-centric strategy, and ambitious plans for growth in new markets. He…