Date: 4th March 2024
Time: 9:30 – 5:30pm
Venue: Scitech Centre 7, Prabhat Nagar, Jogeshwari West, Jogeshwari West, Mumbai, Maharashtra 400102 Mumbai, India
The workshop is free!! Click here to complete and submit form for expression of interest to attend the workshop. The form should be submitted by 15th February 2024
Click here for workshop flyer
- Announcement
- Programme
The University College London (UCL), European Paediatric Formulation Initiative (EuPFI) in partnership with Indian Pharmaceutical Association (IPA), Society of Paediatric Medicines and Healthcare Initiative (PMHI), and ThetaBeta Analgorithm (TBA) is inviting expressions of interest in a workshop to be held on 4th March 2024 at Scitech Centre in Mumbai, to identify and discuss challenges and potential improvements in the development, control and utilization of administration devices for paediatric oral and respiratory medicines.
The research conducted in high and low middle countries have highlighted the issues related to administration devices for children that are prevalent in low-and middle-income countries (LMICs). These are not only user related but also related to regulatory environment, inadequate ecosystem support that impact the development and use of innovative devices in low resource settings. Although oral liquids are acceptable for the whole paediatric age range (birth to 18 years), a key challenge with their administration is to ensure the correct dose is measured. The dose variability may occur where inappropriate devices (eg. oral syringes) that not suitable for the specific drug product are used and dose being administered, leading to under dosing with diminished treatment efficacy or overdosing with potential for toxic effects.
A multi-dimensional/multi stakeholder strategy is needed to improve the administration of medicines to children using the appropriate dosing devices. Hence, this stakeholder workshop is being planned that aims to create a dynamic platform where researchers, device engineers, industry leaders, policymakers, healthcare professionals, and end-users converge to foster a vibrant ecosystem of innovation in administration device development. It will help facilitate the establishment of an optimal path towards the correct dosing to paediatric patients with appropriate administration devices, that meets the requirements of all stakeholders involved (Patients, Regulators, Practitioners and Industry).
The workshop will gather experts in developing, prescribing, and administering medicines to children in Low Middle-Income Countries (LMICs), with a focus on India, China, Nigeria, Thailand, as well as High-income countries (HICs) like the UK, US, and Europe. Various stakeholders, including patients/caregivers, healthcare professionals, representatives from the pharmaceutical industry, drug delivery device suppliers, and academia, are invited. Additionally, representatives from national competent authorities and institutions across regions like Japan, Nigeria, US, UK, and EU are also welcome..
The workshop will include presentations from keynote speakers and break-out sessions for discussion on specific topics.
The workshop is free. The places are limited and only selected participants will be invited to participate.
Click here to complete and submit form for expression of interest to attend the workshop. The form should be submitted by 15th February 2024
Places are limited and will be allocated to ensure a fair representation of all stakeholder groups and organisations, and so please do not book travel arrangements until your attendance has been confirmed.
A report of the workshop, the action plan and presentations from the workshop will be published on this website.
Background and Objectives
Background
A key challenge with the administration of medicines is to ensure the correct use of administration device and dose measured. Dose variability may occur where inappropriate devices are used and dose being administered, leading to under dosing with diminished treatment efficacy or overdosing with potential for toxic effects.
EuPFI/UCL in partnership with IPA, PMHI and TBA is organising a one-day workshop that will bring together a broad range of stakeholders, including patients/caregivers, healthcare professionals and representatives from the pharmaceutical industry, drug delivery device suppliers and academia to share current practices and issues regarding the development and handling of administration devices for children in low resource settings, to facilitate awareness and identify areas for improvement and innovation.
Objectives
- To give an overview of the main challenges associated with the administration of oral and respiratory medicines to the paediatric population in both a hospital and domiciliary setting, including practical considerations.
- To review factors (e.g. users, environment, design and technical factors) that have an impact on accurate administration of doses routinely prescribed to paediatrics, and practical considerations for dosing small volumes.
- To share current practices and challenges associated with the development, control and supply of oral and respiratory administration devices
- To describe the requirements and regulations industry must comply with and how industry develops, selects or assesses the administration devices.
- To exchange ideas on what can be improved to achieve a safer administration of medicines to paediatrics.
- To create awareness about the importance of such devices in improving healthcare for children in low resource settings.
Workshop Agenda
Time | Topic | Presenter |
09:30 | Arrival, Registration and Poster Viewing | |
09:30 | Welcome address | Smita Salunke, European Paediatric Formulation Initiative (EuPFI) & University College London (UCL) School of Pharmacy, United Kingdom Vandana Patravale, Society for Paediatric Medicines & Healthcare Initiative (PMHI), India Alka Mukne, Indian Pharmaceutical Association (IPA), India Pradeep Behera, Theta Beta Analgorithms (TBA), India |
09:45 | Introduction and Workshop Objectives | Smita Salunke, EuPFI & UCL School of Pharmacy, United Kingdom |
09:55 | Topic 1: Snapshot of global landscape on the use of administration devices for paediatric medicines followed by panel round table | Chair: Esmeralda Hermans, J&J Innovative Medicines, Belgium. Usability of adminsitration devices for oral and respiratory medicines Elisa Alessandrini, UCL School of Pharmacy, United Kingdom Panelist Jumpei SElisa Alessandrini, UCL School of Pharmacy, United Kingdomito and Hidefumi Nakamura National Center for Child Health and Development, Japan Elisa Alessandrini, UCL School of Pharmacy, United Kingdom Sushama Talegoankar, Delhi Pharmaceutical Sciences and Research University, India Min Zhao, School of Pharmacy/China Medical University-QUB Joint College (CQC) Queen’s University Belfast (QUB) Emmanuel Chukwuebuka Umeyor, Nnamdi Azikiwe University, Nigeria |
10:40 | Coffee Break | |
11:00 | Topic 2: Stakeholders’ perspective on challenges associated with the administration of oral liquid medicines to the paediatric population | Chair: Pradeep Behera, Theta Beta Analgorithms, India |
11:00 | Healthcare professionals’ perspectives (challenges and measures) | Sridhar Ganapathy, Janani Children’s Hospital, Mumbai, India |
11:20 | Pharmaceutical industry perspectives ((development of product – points to consider in terms of device) | Esmeralda Hermans, J&J Innovative Medicines, Belgium. Abhishek Telang, Merck, United States |
11:50 | Administration device suppliers’ perspectives ((development and supply issues) | Anand Hiremath, Aptar Pharma, India |
12:10 | Q&A session | |
12:25 | Lunch Break | |
13:45 | Forum discussion, Group Feedback and Discussion Stakeholders’ perspective on overcoming challenges to achieve a safer administration of medicines to paediatrics patients • Which procedural and operational challenges in relation to administration of oral and pulmonary medicines to the paediatric population in both a hospital and domiciliary setting (dosing devices, dosing accuracy etc) should be addressed? • What are constructive solutions that could facilitate the establishment of an optimal path towards the correct oral and pulmonary dosing of all paediatric patients, that meets the requirements of all stakeholders involved | Moderators: Smita Salunke, EuPFI & UCL School of Pharmacy, United Kingdom, Vandana Patravale, Society for Paediatric Medicines & Healthcare Initiative (PMHI), India Alka Mukne, Indian Pharmaceutical Association, India Pradeep Behera, Theta Beta Analgorithms, India Esmeralda Hermans, J&J Innovative Medicines, Belgium. |
14:50 | Feedback from each group (5 min each) | |
15:10 | Break & Affinity Mapping | |
15:40 | Inside out -A closer look at rectal capsule for drug administration | Chair: Catherine Tuleu, EuPFI & UCL School of Pharmacy, United Kingdom, Speaker – Dr. Parizad Elchidana, Associated Capsules Group World, India |
16:00 | Topic 3: Overview of regulatory expectations and requirements of paediatric administration devices. Example case studies where data have been provided/ questions have been raised regarding the administration of an oral or pulmonary medicine using an administration device. | Chair: Alka Mukne, Indian Pharmaceutical Association, India |
16:00 | Regulatory perspectives (Overseas) | Gary Inwards, MHRA, United Kingdom |
16:20 | Regulatory perspectives (Indian) | K Bangarurajan, Adviser CDSCO Central Drugs Standard Control Organization, India. |
16:50 | Panel discussion | Panelist K Bangarurajan. Adviser, Central Drugs Standard Control Organization, India Jayant Kumar. Asst. Drugs Controller, CDSCO,India Gary Inwards, MHRA ,U n i t e d K i n g d o m EMA representative – TBC |
17:10 | Conclusion and next steps | Smita Salunke, EuPFI & UCL School of Pharmacy, United Kingdom |
17:30 | End of workshop |