EMA annual report reviews actions in 2022
The European Medicines Agency (EMA) has published its annual report for 2022, highlighting its challenges and successes in a year that saw it face ongoing and new public health emergencies.
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US FDA issues draft guidance on decentralised clinical trials
Decentralised clinical trials (DCTs) are being used increasingly in the pharma industry for clinical research and the US Food and Drug Administration (FDA) has published draft guidance for those carrying out trials at non-traditional investigation sites.
Will ABPI’s ambitious VPAG plans succeed VPAS?
Discussions are beginning on the next iteration of the UK’s voluntary scheme for branded medicines, pricing and access (VPAS) and the Association of the British Pharmaceutical Industry (ABPI) has set out its stall to government. It has published a four-point proposal for a Voluntary Scheme for Pricing, Access and Growth (VPAG), designed to reignite competitiveness and boost innovation in the life sciences sector, thereby improving health outcomes and the wider economy.
EC’s plans for updating pharma legislation unveiled
The European Commission’s (EC) long-awaited proposals for reforming pharma legislation have been published. The main thrust of the proposals is to create a single EU market for medicines to replace existing fragmentation and improve access for EU citizens.
The 2023 ABPI annual conference focused on growing the Life Sciences
The 2023 annual conference of the UK’s Association of the British Pharmaceutical Industry (ABPI) at the end of April had a theme of Growing the UK as a Global Hub for Life Sciences.
Breakfast Briefing Takeaways: So you want to be a Pharma consultant?
When setting up as a pharma consultant, it can be difficult to know how to structure the business and what sort of insurance is required. In PMC’s latest virtual breakfast briefing, PharmaMedic’s Managing Director Dr Malcolm Barratt-Johnson was joined by guest speaker Simon Wyndow, All Med Pro's Life Sciences insurance manager, to outline the different options that should be considered.
EFPIA Director General calls for action on pharma legislation
The head of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Nathalie Moll, has outlined two urgent actions that European pharma needs as the announcement of the EU’s pharma strategy has been postponed again by the European Commission.
Current IR35 rules and how they affect consultants
What points need to be considered when setting up as a pharma consultant in the UK? From the type of business to establish, to insurance and off-payroll taxation requirements, there are many factors to contemplate. Read on for an overview of the current IR35 tax rules and sign up for our free webinar, ‘So you want to be a Pharma consultant? Company structure and insurance implications’.
Government confirms increase to pharma’s statutory scheme
Despite opposition from the Association of the British Pharmaceutical Industry (ABPI), the UK government has confirmed its plans to raise the revenue clawback rate paid by pharma for branded medicines under the statutory scheme by just over 3%, from 24.4% to 27.5% for 2023.
Breakfast briefing takeaways: Quality Systems in Pharma – Who, What, When?
In our latest online breakfast briefing, PharmaMedic Consultancy’s Managing Director Malcolm Barratt-Johnson, welcomed Indira Walker of Iolite Pharma Consulting, to discuss the requirements for maintaining quality across the medicine development and manufacturing process, and the important role of the Qualified Person at every stage. Read on to discover the key points that should be considered to ensure success throughout the product life cycle – and how the QP is an integral part of that journey.