Tag Archives: children

EMA Improves Package Leaflets

Posted on September 23, 2011 by admin| Leave a comment

EMA Improves Package Leaflets

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The European Medicines Agency has updated the template for package leaflets for human medicines, to make the information easier for patients to understand and to include new sections on medicines’ benefits and their uses in children.

The Agency introduced these changes to contribute towards the safe and effective use of medicines. They address the feedback from five years of user testing and from a range of stakeholders, including patient and consumer groups, national medicines regulatory agencies, the pharmaceutical industry and academics.

This feedback included concerns that the package leaflet needed to be more readable with fewer rigid standard statements, and that patients needed more information on the benefits that medicines can bring and on their uses in children.

The update also takes the Agency’s report on the expectations of patients, consumers and healthcare professionals regarding benefit-risk information into account, as well as the requirements of the paediatric regulation.

The Agency’s Working Group on Quality Review of Documents introduced these changes as part of the latest revision of the human product information templates.

In addition to the package leaflet, the revision included changes to the templates for the summary of product characteristics, labelling, and ‘annex II’, the section of the product information covering the conditions imposed on marketing authorisations.

The updated templates are available in all official European Union languages, as well as Icelandic and Norwegian, together with an implementation plan. Versions of the templates showing the latest updates as ‘tracked changes’ are also 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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EMA Seeks Expression of Interest in Workshop on Ethics of Children in Clinical Trials

Posted on September 21, 2011 by admin| Leave a comment

EMA Seeks Expression of Interest in Workshop on Ethics of Children in Clinical Trials

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The European Medicines Agency is inviting expressions of interest for its workshop on the ethical considerations for paediatric trials, taking place at the Agency on 29-30 November 2011.

Expressions of interest are welcome from people with a scientific background or paediatric experience of ethics committees, paediatric research networks, the pharmaceutical industry or contract research organisations.

The meeting will bring together members of ethics committees assessing paediatric trials, the Agency’s Paediatric Committee (PDCO) and methodology experts from the European regulatory network.

It will enable:

  • the exchange of experience and views on ethical questions in the design of paediatric trials and assessment of the ethical aspects of paediatric trials;
  • the exploration of ways to collaborate and share information;
  • discussion of how the PDCO requests paediatric trials;
  • the exploration of opportunities for the safeguard of children by ethics committees and the European regulatory network, while fostering excellence in the development of medicines for children.

For more detailed information and to express interest in participating, please contact Dr Ralf Herold.



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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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NICE Publish Guidance on Food Allergy in Children

Posted on March 12, 2011 by admin| Leave a comment

NICE Publish Guidance on Food Allergy in Children

Food allergy is an adverse immune response to a food. Food allergy is one of the most common allergic disorders and is recognised as a major paediatric problem in western countries. Its prevalence has increased dramatically in recent decades. There is great variation in current practice for allergy care, and there are no agreed treatment pathways or referral criteria. Many people use alternative sources of support instead of NHS services, including non-validated tests and treatments.

Treatment and care should take into account the individual needs and preferences of children and young people with possible food allergy, and those of their parents and carers. Good communication is essential, supported by evidence-based information, to allow children and young people and their parents and carers to reach informed decisions about their care. Follow advice on seeking consent from the Department of Health or Welsh Assembly Government if needed.

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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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NICE Publish Reference Guide on Food Allergy in Children

Posted on March 4, 2011 by admin| Leave a comment

NICE Publish Reference Guide on Food Allergy in Children

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Food allergy is an adverse immune response to a food. Food allergy is one of the most common allergic disorders and is recognised as a major paediatric problem in western countries. Its prevalence has increased dramatically in recent decades. There is great variation in current practice for allergy care, and there are no agreed treatment pathways or referral criteria. Many people use alternative sources of support instead of NHS services, including non-validated tests and treatments.

Treatment and care should take into account the individual needs and preferences of children and young people with possible food allergy, and those of their parents and carers. Good communication is essential, supported by evidence-based information, to allow children and young people and their parents and carers to reach informed decisions about their care. Follow advice on seeking consent from the Department of Health or Welsh Assembly Government if needed.

Food allergy can be classified into IgE-mediated and non-IgE-mediated allergy. IgE-mediated reactions are acute and often have a rapid onset. Non-IgE-mediated reactions are generally characterised by a delayed and non-acute onset. Mixed reactions involve a mixture of both IgE and non-IgE responses.

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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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NICE Publishes Guidance on Sedation in Children and Young People

Posted on December 31, 2010 by admin| Leave a comment

NICE Publishes Guidance on Sedation in Children and Young People.

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Advances in the treatment of paediatric diseases has led to an increase in the number of painful or distressing diagnostic or therapeutic procedures for which many children will need effective sedation or anaesthesia. The choice between sedation and anaesthesia will depend on the type of procedure. Some procedures are very common and healthcare providers and
practitioners need to understand under which circumstances either sedation or anaesthesia is most cost effective.

In adults, many procedures can be undertaken with local anaesthesia and reassurance. In children and young people this is often not possible because the procedures are too frightening, too painful or need to be carried out in children who may be ill, in pain or have behavioural problems.

The aims of sedation during diagnostic or therapeutic procedures include reducing fear and anxiety, augmenting pain control and minimising movement. The importance of each of these aims will vary depending on the nature of the procedure and the characteristics of the patient.

There are many sedation techniques available but there is insufficient guidance on which techniques are effective and what resources, including staff training, are required to deliver them safely.

Sedation is not always effective enough and so occasionally the procedure has to be delayed until the child or young person can be anaesthetised. This may need to take place in a different healthcare setting or on another day. Consequently, sedation failure is distressing for the child or young person and also has major NHS cost implications.

Excessive sedation can cause unintended loss of consciousness and dangerous hypoxia. Planned anaesthesia, in comparison, is effective but might have resource implications.

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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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NICE Publish Appraisal for Omalizumab in Allergic Asthma

Posted on November 6, 2010 by admin| Leave a comment

NICE Publish Appraisal for Omalizumab in Allergic Asthma

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Omalizumab is not recommended for the treatment of severe persistent allergic asthma in children aged 6 to 11 years.

Children currently receiving omalizumab for the treatment of severe persistent allergic asthma should have the option to continue treatment until it is considered appropriate to stop. This decision should be made jointly by the clinician and the child and/or the child’s parents or carers.

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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, Publishes Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Posted on August 29, 2010 by admin| Leave a comment

EMA, Publishes Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

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Attention Deficit Hyperactivity Disorder (ADHD) is among the most common disorders in child- and adolescent psychiatry. Its impact on learning and development is considered substantial. The benefit of pharmacotherapy has empirically been proven, and several products are on the market. Although primarily a disorder diagnosed in childhood and adolescence, signs and symptoms may not be selflimiting but may persist into adulthood. These new insights in the ADHD syndrome are a challenge in the field of drug development. However, this Guideline is intended to provide guidance on the evaluation of new medicinal products in ADHD with focus on the childhood onset. It is the first guideline written in psychiatry to address a (child) psychiatric disorder from this perspective, and it should be read in conjunction with other EMA and ICH  guidelines, which may apply to similar conditions and patient populations.

Attention Deficit Hyperactivity Disorder, ADHD, is a well defined disorder with core features of inattention, hyperactivity, and impulsivity, but also impairment in executive functions. It has its origin in childhood and is often diagnosed for the first time in school-aged children because of learning problems and problems with social behaviour. Treatment is therefore directed towards improvement of attention and reduction of hyperactivity/impulsivity in order to be able to focus on tasks and performance, and improve associated behavioural and relational problems. Methylphenidate is among the first effective drugs reported to treat the ‘hyperkinetic syndrome’ in the 1950s.  Although often regarded as the standard of treatment, new products have come to the market, e.g. atomoxetine with a different mode of action. Psycho-education, and psycho-education in combination with pharmacotherapy are usually the standard of care in Europe, and behavioural treatment is often provided to sustain success of pharmacotherapy, and to modify conduct problems. In the context of non-pharmacological interventions, cognitive treatment, neurofeedback training and dietary  measures can be regarded as potential, but not yet evidence based strategies. It has long been assumed that the core symptoms of ADHD ameliorate with age. It has recently been recognized that symptoms and impairments may persist into adulthood, thereby extending treatment to this age group. Usually, inattention and restlessness predominate at adult age, interfering with work and social functioning. As ADHD is a chronic disorder, long term treatment can be foreseen, thereby emphasizing the need for
long term safety data in a group of patients that does include many otherwise healthy individuals.

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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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Drug Regulators, EMA, Publish Reflection Paper on Ethanol Content in Herbal Medicinal Products and Tranditional Herbal Medicinal Products Used in Children

Posted on February 9, 2010 by admin| Leave a comment

Drug Regulators, EMA, Publish Reflection Paper on Ethanol Content in Herbal Medicinal Products and Traditional Herbal Medicinal Products Used in Children

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Herbal medicinal products may contain significant levels of ethanol arising from its use as an extraction solvent in liquid extracts and tinctures or when added as a diluent to liquid herbal preparations. The use of ethanol is necessary for extraction of some constituents that are important for efficacy. Ethanol is metabolically active, therefore formulations without ethanol or with the lowest achievable level should be selected to avoid systemic exposure when the target population is children.

The scope of this paper is to reflect the need for safety limits for ethanol exposure by oral herbal medicinal products intended for the paediatric population. Establishing these limits is viewed as necessary to protect health and to allow safe free movement of goods within the EU. In addition, this will ensure a harmonised approach in assessment work among Member States as well as in the establishment by the HMPC of Community herbal monographs and of the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (respectively Article 16h (2,) and Article 16f (3) of Directive 2001/83/EC as amended).

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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