Tag Archives: medicines

MHRA Publish Guidance for Journalists Reporting on Medicines

MHRA Publish Guidance for Journalists Reporting on Medicines.

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Health issues always hit the headlines and access to health information is important in empowering people to make informed decisions about their health care. Articles often draw attention to a prescription only medicine (POM) or results from trials on new products still in research. Yet the advertising legislation prevents these medicines being advertised to the public and the law applies to ‘any person’ – not just pharmaceutical companies. So what do journalists and patient organisations need to do to ensure they stay within the law when writing about medicines? Reporting information fairly and accurately while ensuring a balanced view is represented is paramount. Paying attention to these will help ensure the ban on advertising prescription medicines does not become an issue. The bottom line is – keep it factual and balanced to keep out of the advertising controls.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Announces Global Animal Health Conference

EMA Announces Global Animal Health Conference

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This conference provides an excellent platform to discuss the opportunities and challenges of ensuring an adequate supply of up-to-date medicines to meet the needs of animals around the world, bearing in mind the one world, one health concept underlining that health in animals promotes health in humans. Registration open until 23 March 2011, limited places available.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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EMA Announce Workshop on Nano-Medicines

EMA Announce Workshop on Nano-Medicines

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On 2-3 September 2010, EMA hosted the first international scientific workshop on nanomedicines. Some 200 European and international participants from 27 countries including Australia, Canada, India, Japan and the United States discussed benefits and challenges arising from the application of nanotechnologies to medicines. Participants included representatives from patients’ organisations, health care professionals’ organisations, academia, regulatory authorities and pharmaceutical industry.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

Drug Regulators, MHRA, extend deadline on Nicotine Containing Products Review to 2nd June

Drug Regulators, MHRA, extend deadline on Nicotine Containing Products Review to 2nd June

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There are consulting with you on whether to bring all nicotine containing products (NCPs) – with the exception of tobacco and tobacco products – within the medicines licensing regime, which would require all currently unlicensed NCPs on the market, such as electronic cigarettes containing nicotine and nicotine gels, to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a medicines marketing authorisation (MA).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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ida consultants freestrategyconsultation 515x64 Drug Regulators, MHRA, extend deadline on Nicotine Containing Products Review to 2nd June

Free Strategy Consultation - Biotech Pharma Regualtory

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Drug Regulators, MHRA, Publish Consultation Letter MLX 364, The Regulation of Nicotine Containing Products

Drug Regulators, MHRA, Publish Consultation Letter MLX 364, The Regulation of Nicotine Containing Products.

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The MHRA are writing to consult you on whether to bring all nicotine containing products (NCPs) – with the exception of tobacco and tobacco products – within the medicines licensing regime, which would require all currently unlicensed NCPs on the market, such as electronic cigarettes containing nicotine and nicotine gels, to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a medicines marketing authorisation (MA).
This consultation should be read in conjunction with the draft Impact Assessment (IA). We would welcome views on whether to bring unlicensed NCPs within the medicines licensing regime. All replies will be considered before a final decision is made.

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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ida consultants freestrategyconsultation 515x64 Drug Regulators, MHRA, Publish Consultation Letter MLX 364, The Regulation of Nicotine Containing Products

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

ida 100programme 515x64 LowRes Drug Regulators, MHRA, Publish Consultation Letter MLX 364, The Regulation of Nicotine Containing Products

Drug Regulator, MHRA, Starts Consultation on Measures to Strengthen the Medicines Supply Chain and Reduce the Risk of Counterfit Medicines

Drug Regulator, MHRA, Starts Consultation on Measures to Strengthen the Medicines Supply Chain and Reduce the Risk of Counterfeit Medicines

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This consultation meets the MHRAs commitment to undertake a further consultation on specific proposals designed to strengthen the medicines supply chain in the UK. It follows and builds on responses to ideas set out in an earlier consultation (MLX357) undertaken from 18 December 2008 – 13 March 2009. The overall aim of these proposals is to provide a significant strengthening of controls over the movement of medicines throughout the legitimate supply chain and provide greater protection against the risk of counterfeit medicines reaching patients in the UK.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulator, MHRA, Starts Consultation on Measures to Strengthen the Medicines Supply Chain and Reduce the Risk of Counterfit Medicines

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