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The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Using artificial intelligence in drug discovery and development could have huge benefits for companies, but a key challenge will be addressing how data is used to train AI tools and managing intellectual property issues, says Clifford Chance’s Stephen Reese.
As healthcare shifts rapidly into the home, clinical trials are only beginning the long transition needed to keep up.
Human-centric design, a risk-based approach and lifecycle management are among the ten guiding principles for artificial intelligence (AI) that pharma should follow when using AI in the drug lifecycle, the FDA and EMA say in a joint document.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Preference research is a large and evolving field, says the International Council for Harmonisation.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Flagship Pioneering is first partner in initiative aimed at giving drug developers early, informal, joint advice to fast-track the ‘most promising’ health care innovations. Pathway builds on an artificial intelligence collaboration between the UK MHRA and Singapore’s Health Sciences Authority.
New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.
Postmarket optimization studies for cancer drugs can strengthen clinical trust in cancer medicines, which in turn results in therapies being used more often, a researcher says.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Incentives are “probably the only solution” to encouraging companies to optimize cancer drugs, but this will require funding and systemic changes, the chair of the European Medicines Agency’s oncology working party says.
New Zealand is also lifting its prohibition on advertising unapproved medicines at medical conferences and trade shows in order to boost its appeal as a host for such events and generate millions of dollars in revenue.
‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change
Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.
Horizon scanning is a tool used by regulators to prepare for forthcoming medicines that might challenge existing processes. Senior figures from the European Medicines Agency, Swissmedic and the UK MHRA explain how they conduct horizon scanning activities in their respective jurisdictions.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Lawler, who leads the Therapeutic Goods Administration, has replaced the European Medicines Agency’s Emer Cooke as chair of the International Coalition of Medicines Regulatory Authorities.
Recipients of the public-private funding are also expected to receive wraparound support, including strategic guidance to identify the right progression pathway for their antimicrobial resistance asset and access to key resources and sector connections.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.