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Dry Powder Inhalers Training Course
A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design
*FULLY UPDATED PROGRAMME*
23-24 Jun 2021
Details
Conference overview
The global dry powder inhaler (DPI) market is expected to grow at a robust rate over the next few years. The growing prevalence worldwide of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) is one of the major factors fuelling this growth with a rising demand for advance healthcare devices for the treatment of these chronic diseases.
This annual two-day seminar will provide a comprehensive review of all the key aspects of DPIs including therapeutic targets, the latest delivery technologies and the current regulatory landscape. Participants will gain a valuable insight into market potential, respiratory diseases and key treatment guidelines, formulation, stability testing, characterisation studies, device design, human factors, quality by design (QbD) and the manufacturing process. Intellectual property, bioequivalence and the opportunities of connectivity with DPIs will also be addressed.
This must-attend event will include practical workshop sessions and provide a unique opportunity to discuss DPIs with fellow professionals and our expert faculty of speakers who all have significant expertise in this field.
- Know the market potential
- Clarify the therapeutic targets
- Gain an insight into delivery technologies
- Consider key treatment guidelines
- Understand the formulation challenges
- Discuss essential aspects of DPI QbD medicine development
- Obtain key information on device design and human factors
- Know the regulatory pathways to follow
- Consider bioquivalence (in-vitro vs in-vivo)
- Consolidate learning with interactive workshops and discussion sessions
Media Partners
Who should attend
This event will be beneficial to all those new to the area and those who require a refresher on the opportunities and challenges with this technology. The content will appeal to pharmaceutical scientists, formulation scientists and analysts, device designers and specialists in industrialisation, quality assurance and regulatory affairs who may want to gain an understanding of both the history of and current practices in DPI development and manufacture in the pharmaceutical industry. It will be of benefit to individuals with an interest both in innovative and generic products and the associated international regulatory expectations associated with DPI products.
Professionals from associated industries such as primary packing suppliers, excipient (used in DPIs) producers, DPI equipment designers and manufacturers for unit processes who wish to understand the scope of DPI respiratory medicine development will also find this seminar useful.
Media partners and exhibitors
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Exhibitors
Programme
Markets and trends for respiratory medicines (MDIs, nebulisers, DPIs)
- Global overview
- Developed vs emerging markets
- Cost – value – price
- Environmental impacts – a new opportunity?
- NICE guidance on using DPIs
- Changes in therapies
Respiratory diseases/treatments/guidelines
- Asthma
- COPD
- Other lung diseases
- Treatments and medicines
- Ancient and new
- Lung disease treatment guidelines
- Global Initiative for Asthma (GINA)
- Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Aim of formulating respiratory medicines
- Single and multi-dose systems
- The patient – human factors engineering (HFE)
- Manufacturing processes and systems
- DPI unit processes
Device design
- General principles (historic)
- The optimum design process
- Considerations
- The role of design control (ISO and CFR)
- Innovation vs generic approaches
- What documentation do I need?
- Materials strategies
- A global approach
Medicine testing/stability/ characterisation studies
- DPI testing
- Aerodynamic particle size distribution (APSD) etc
- Stability (regional vs global strategy)
- Characterisation studies
- Bioequivalence (in-vitro vs in-vivo)
WORKSHOP ONE: Device Design
DPI QbD medicine development
- Quality target product profile (QTPP)
- Critical quality attributes (CQAs)
- Critical process parameters (CPPs)
- Developing control strategy
Regulatory requirements and considerations
- Combination product initiatives
- MDD vs MDR
- Usability/human factors (US vs EU)
- CTD changes
- New (!) guidances
- Current best practice
- Communication approaches
- Risk management
- Post-market activity (device)
WORKSHOP TWO: Quality by design
Intellectual property
- Overview of the landscape
- When, what and how
- Novelty vs infringement vs obviousness
- The concepts of soft and hard IP
- Resources
Connected medicine
- Current DPI products
- Fact or fiction
- Unique selling points (USPs)
Presenters
Mike Holroyd (More...)
Mike Holroyd is Senior Director with responsibility for the design, development and scale-up of inhalation devices within the Mylan Global Respiratory Group. He has an MA in Engineering from St. Catharine’s College, Cambridge. He started his career at Rolls-Royce Aero engines, before moving to PA consulting group where he was a Partner and manager of the product development group. He then joined Norton Healthcare in 1993, where he directed all inhalation device development, including engineering, formulation development and analytical laboratory services and the subcontract manufacture of devices. At Norton he developed, scaled-up and launched Easi-Breathe as well as developing the Spiromax MDPI. He was awarded the Royal Academy of Engineering MacRobert award for the development of Easi-Breathe.
He left Noton (now part of IVAX) to start his own consultancy business, before joining Phoqus Pharmaceuticals as Vice President Engineering to develop novel drug delivery systems based on electrostatic deposition technology. He then returned to consultancy, operating as Programme Director on a major new respiratory device development, until he joined Myland in 2013.
David Howlett (More...)
In 2003 David established PharmaDelivery Solutions Ltd as a specialised consultancy service in the field of drug delivery combination products (especially respiratory) device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis and generation of documentation supporting development and test programmes, together with data review and contingency evaluation.
David has over 35 years experience in the development, industrialization and approval of inhalation drug delivery systems, combination products and medical devices.
PharmaDelivery Solutions Ltd has provided input ranging from GAP analysis and comment to complete remedial implementation in areas including
• Design Control
• Risk Management
• Materials strategies
• Regulatory documentation
• Technical reviews and opinion
In addition to activities supporting commercial organizations, David has been involved in the following roles;
Honorary Teaching Fellow in the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester and is author/ tutor for the Pharmaceutical Industry Advanced Training (PIAT) MSc module on Inhalation dosage forms.
A UK national expert representing the British Standards Institute on ISO TC84 developing new international standards for pulmonary and nasal delivery devices syringes and catheters.
David has also worked with the United Nations and various national governments to develop and establish transition strategies from the use of CFC in Metered Dose Inhalers and to secure appropriate budgets from the Multi-lateral fun for the implementation of the Montreal Protocol in emerging markets around the world.
Helen Muirhead (More...)
Helen now is an independent Respiratory Medicine Expert, acting as a consultant after 30 years with GSK in both R&D and Manufacturing. Helen is also now involved in teaching at Universities and supports Lung Disease charities.
In GSK, Helen headed up the Respiratory Centre of Excellence during the late stages of Product Development through Regulatory Filing and Commercial Launch and supply of new Medicines – in the Ellipta Portfolio (Including the recent Trelegy, triple drug therapy). Helen was also responsible for the classic and establish brands; the existing Diskus Portfolio (Including Advair).
Helen and her team were based in Ware (UK), Evreux (France) and Zebulon (USA): it comprised of Pharmacists, Chemists, Material Scientists, Engineers and Device designers and she was Accountable for the robustness and reliability of the Respiratory Products and Processes, as well as the skills and competency of the Global Respiratory Technical Organisation.
Helen was also the Technical Lead on the Global Ellipta and Diskus Manufacturing Excellence Forums.
A Fellow of the Royal Society of Chemistry, with 42 years of Industrial experience from Quality Control, Quality Assurance, Analytical method development, including 15 years in R&D Respiratory Product Development (in pMDIs and DPIs development), through Clinical Trials Design and manufacturing… heading up the Respiratory Pilot Plant. Helen has been in Technical roles within Manufacturing for 15 years.
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23-24 Jun 2021 Face-to-face, (venue not yet confirmed) |
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23-24 Jun 2021 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 12 May* |
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