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WEBOn April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”). The Approach …

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WHO Publishes Regulatory Considerations on AI for Health

WEBOn October 19, 2023, the World Health Organization (“WHO”) published a set of regulatory considerations on artificial intelligence (“AI”) for health (press release and full …

Category: Health Go Health

New German Government plans significant changes with Impact …

WEBAdem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & …

Category: Food, Medical Go Health

Consultation on the Future Regulation of Medical Devices in the …

WEBThe Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United …

Category: Medical, Medicine Go Health

Pathogen Access and Benefit-Sharing (P-ABS) under the draft …

WEBBy May 2024, the 194 countries of the World Health Organization (“WHO”) aim to finalize negotiations on a new international treaty on pandemic prevention, …

Category: Health Go Health

EMA Releases Reflection Paper on AI/ML in the Medicinal Product

WEBThe EMA has therefore published a draft “ Reflection paper on use of Artificial Intelligence (AI) in medicinal product lifecycle ” (the “ Draft Reflection Paper ”), which is …

Category: Health Go Health

Germany again to reform drug pricing and reimbursement laws – …

WEBAdem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & …

Category: Food, Medical Go Health

European Health Union: European Commission proposes Changes …

WEBOn 11 November 2020, the European Commission has announced a range of proposals to build a European Health Union. The proposed measures reflect on the learnings from …

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Major Cyber-Attack on Irish Health System Causes Commercial …

WEBOn May 20, 2021 there was a major ransomware attack on the Irish health system. The centralized HSE (Health Service Executive) which provides and manages healthcare for …

Category: Health Go Health

New Early Access and Off-Label Use Rules in France

WEBBy Bart Van Vooren & Peter Bogaert on July 6, 2021. On 1 July 2021, the new French rules on early access to unauthorized medicinal products and off-label use of …

Category: Health Go Health

Regulatory Watch: How has recent Law No 2019-774 of 24 July …

WEBGrant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, …

Category: Health Go Health

The New Italian Sunshine Act: What Companies Should Know And …

WEBAdem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & …

Category: Food, Medical Go Health

Entry Into Force of Reinforced Anti-gift Rules in France

WEBToday, October 1st 2020, the updated anti-gift scheme in France enters into force. The anti-gift rules impose obligations on pharmaceutical, medical device and cosmetics …

Category: Medical Go Health

Belgium Amends Compassionate Use and Medical Need Program …

WEBOn 13 December 2020, Belgium amended its rules regarding compassionate use and medical need programs to confirm that authorized programs can continue to …

Category: Medical Go Health

NutriScore Halted In Italy As Italian Competition Authority Deems …

WEBOn 1st August 2022, the Italian Competition Authority (“AGCM”) published its decision where it ruled that the NutriScore labelling must be discontinued in Italy because it …

Category: Health Go Health

UK MHRA to recognize foreign regulatory approvals for medicines …

WEBAdvising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software …

Category: Medical Go Health

UK Government Announces Launch of Pilot Scheme to Accelerate …

WEBAdvising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software …

Category: Medical Go Health

German Government pursues new Pharma Strategy with …

WEBAdem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & …

Category: Food, Medical Go Health

CJEU Rules on the Advertising of “Unspecified Medicinal Products” …

WEBAdem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & …

Category: Food, Medical Go Health