Metered Dose Inhaler (MDI) Technology Training Course
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
13-14 Sep 2022
Details
Course overview
This interactive seminar will provide a comprehensive overview of metered-dose inhaler technology, giving participants a valuable insight into market potential and recent industry trends. The programme will clarify the therapeutic targets and look at the various delivery technologies available. There will be detailed coverage of the manufacturing process, equipment and options, together with quality and inspection requirements, human factors and bioequivalence. Our highly experienced trainer will address the regulations applying to inhalation products and provide guidance on the regulatory pathways to follow.
The event will benefit those new to this area and will also be of value to anybody who requires a refresher on the opportunities available with this technology. The seminar format will include practical workshops, which past delegates have found invaluable, and ample opportunity for discussion on any specific issues with an expert in this field.
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Who should attend?
- Respiratory pharma professionals who need to understand MDI technology and its opportunities
- Medical device professionals new to working in the area of MDIs or those who need a refresher
- Medical device business development managers
- Respiratory professionals in R&D
- Medical device manufacturers working in the respiratory market
Programme
Therapeutic targets
- Very brief history
- Asthma
- COPD
- Other local
- CF
- Systemic
- Why?
- Why not?
- Key characteristics
- Particle size
- Why?
Markets
- Disease distribution
- Historic
- Current
- Future
- Drivers
- Manufacture vs use
- International procurement
- Double and triple counting
- Regulation
- Geographic differences
- Pricing
- vs cost
- vs market
- vs product
Delivery technologies
- Inhalation
- MDI
- DPI: unit dose, multi-dose, reservoir
- Nebuliser: energy source, SMI, other
- Other
- Oral
- Injectable
- Nasal
- Cost considerations
- Design
- Scale
- Investment
- Cost of goods
- Typical breakdown
- Sensitivities
Workshop I
- Ranking of competitive technologies for different opportunities
The MDI – overview
- Hardware
- Valves
- Canister
- Actuators
- Sources
- Formulations
- Solution
- Suspensions
- Other
The MDI – manufacturing process
- Process
- Single-stage
- Multi-stage
- Cold
- Flow
- Areas
The MDI – manufacturing equipment
- Scale
- Lab
- Small
- Medium
- Large
The MDI – quality and inspection
- Incoming
- Release
The MDI – other performance
- Prime and re-prime
- Thermal
Challenges and opportunities for the MDI – development and technical
- Performance
- Stability
- Compatibility
- Hardware availability
- Manufacturing processes/equipment
Challenges and opportunities for the MDI and DPI
- Co-ordination
- Breath actuation
- Breath co-ordination
- Training
- Deposition
- Spacers
- Holding chambers
- Enhancements
- Changing therapeutic approaches
- Once daily
- Combinations
Workshop II
- SWOT MDI vs multi-dose DPI
- SWOT MDI vs soft mist inhaler
Regulation of inhalation products
- Regulatory landscape (EU, US, RoW)
- Generic
- New combination
- New chemical entity
- Time to market
- Success rate
- Key expectations
- Changing environment
- Combination product approaches
- Human factors
- Bioequivalence
Workshop III
- Predictions for inhalation products
- What? When? Why?
Presenter
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.
Book now
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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate
- 40% off the 3rd delegate
- 50% off the 4th delegate
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13-14 Sep 2022 Live webinar 09:00-16:30 UK (London) |
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13-14 Sep 2022 Live webinar 09:00-16:30 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 9 Aug* |
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to attend Live webinar |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.