scholarly journals C4C - Paediatric pharmacovigilance: Methodological Considerations in Research and Development of Medicines for Children – A c4c Expert Group White Paper

2021 ◽  
Author(s):  
Beate Aurich ◽  
Dina Apele-Freimane ◽  
Tobias Banaschewski ◽  
Laurent Chouchana ◽  
Simon Day ◽  
...  
Keyword(s):  
Life Cycle ◽  
Data Collection ◽  
Safety Data ◽  
Expert Group ◽  
Medicinal Products ◽  
Paediatric Drug ◽  
Protocol Development ◽  
Spontaneous Reports ◽  
Data Collection And Analysis ◽  
Methodological Considerations

Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regards to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population specific factors (e.g. more frequent use of off-label/unlicensed drugs). In recognition of these challenges a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development. This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life-cycle of medicinal products which is described in this article. These considerations include practical points to consider for the development of the paediatric section of the risk management plan (RMP), safety in paediatric protocol development and safety data collection and analysis. Furthermore, they describe the specific details of post-marketing pharmacovigilance in children using, for example, spontaneous reports, electronic health care records, registries and record-linkage, as well as the use of paediatric pharmacoepidemiology studies for risk characterisation. Next the details of the assessment of benefit-risk and challenges related to medicinal product formulation in the context of a Paediatric Investigation Plan (PIP) are presented. Finally, practical issues in paediatric signal detection and evaluation are included. This paper provides practical points to consider for paediatric pharmacovigilance throughout the life-cycle of medicinal products for RMPs, protocol development, safety data collection and analysis and PIPs.

scholarly journals P11 Neonatal and paediatric protocol development and drug safety: points to consider for risk management and safety data collection

2019 ◽  
Vol 104 (6) ◽  
pp. e21.2-e22
Author(s):  
B Aurich ◽  
V Elie ◽  
E Jacqz-Aigrain
Keyword(s):  
Risk Management ◽  
Clinical Trials ◽  
Data Collection ◽  
Drug Safety ◽  
Safety Profile ◽  
Safety Data ◽  
Age Group ◽  
Baseline Trial ◽  
Paediatric Drug ◽  
Protocol Development

BackgroundProtocol development for neonatal or paediatric clinical trials needs to take into account the age group specifics of the study population (e.g. pharmacokinetics, reference values for laboratory data and vital signs). Drug safety and risk management for neonatal/paediatric trials require an understanding of how these change throughout childhood. We were interested in reviewing and summarising the literature to identify publications which provide researchers with practical information of how the neonatal/paediatric drug safety profile informs age group specific safety data collection and risk management in the protocol.MethodsPubmed, Embase and regulatory authority (RA) websites were searched for publications up to 31/12/2018 for children (0–18 years). In addition, the bibliography of included publications was reviewed to identify additional publications.ResultsRA websites provided general and disease specific guidance on neonatal/paediatric clinical trials with sections relating to drug safety. No publication was identified describing the practicalities of how the neonatal/paediatric drug safety profile can be included throughout the various sections of a clinical trial protocol. The existing literature was summarised providing an overview of how the neonatal/paediatric drug safety profile supports the development of the various protocol sections. For example laboratory values in the exclusion criteria and safety monitoring sections need to be adjusted for age. Vital sign and psychomotor assessment should be done at least at baseline, trial completion and follow-up. Monitoring of adverse events of interest requires consideration of how these may present in neonatal/paediatric patients.ConclusionsIn order to support the protocol development with regards to neonatal/paediatric drug safety a dual competence in both paediatrics and drug safety is required. This review provides an overview of the practical aspects related to neonatal/paediatric drug safety during protocol development.Disclosure(s)Nothing to disclose

Life Cycle Development of Successful Women-owned Enterprises

2020 ◽  
Vol 3 (4) ◽  
pp. 142-152
Author(s):  
Mohammad Waliul Hasanat ◽  
Kamna Anum ◽  
Ashikul Hoque ◽  
Mahmud Hamid ◽  
Sandy Francis Peris ◽  
...  
Keyword(s):  
Life Cycle ◽  
Data Collection ◽  
Research Work ◽  
Primary Data ◽  
Small Scale ◽  
Data Collection Process ◽  
Theoretical Finding ◽  
Successful Women ◽  
Two Phases ◽  
Life Cycle Development

In developing countries, the role of women in the business sector is continuously improving. As a result, female enterprises have also been encouraged in Pakistan. This study is based on life cycle development phases from which women-owned enterprises have to go through in order to become successful. As a primary data source, face-to-face interviews with owners of successful women-owned enterprises were preferred. The data collection process was divided into two phases i.e. Phase-I and Phase-II. After data collection, qualitative analysis has been performed using NVIVO. Findings provide both generic and specific factors involved in life cycle development of women-owned enterprises. This study provides a detailed view of life cycle development model followed by successful women enterprises. The outcome of this research work is a theoretical finding which can be utilized by entrepreneurs owning small scale enterprises to improve their level of performance. Findings can also be helpful for potentially talented women interested in setting up their own business.

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