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Metered Dose Inhaler (MDI) Technology Training Course: live webinar

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

16-17 Sep 2020

& 16-17 Feb 2021 , 15-16 Sep 2021

Book now

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.

Media Partner

Inhalationlogo

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 day two


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

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 – manufacturing equipment

  • Scale
    • Lab
    • Small
    • Medium
    • Large

The MDI – other performance

  • Prime and re-prime
  • Thermal

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 – quality and inspection

  • Incoming
  • Release 

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

    Book now

      attend Live webinar attend Face to face
    16-17 Sep 2020
    Live webinar
    16-17 Sep 2020
    Live webinar
    GBP 1,099.00
    EUR 1,579.00
    USD 1,786.00
    Until 5 Aug*
    Enrol now
    to attend
    Live webinar
    16-17 Feb 2021
    Live webinar & Face-to-face (venue not yet confirmed)
    16-17 Feb 2021
    Live webinar &
    Face-to-face (venue not yet confirmed)
    GBP 1,099.00
    EUR 1,579.00
    USD 1,786.00
    Until 5 Jan 21*
    Enrol now
    to attend
    Live webinar
    GBP 1,299.00
    EUR 1,819.00
    USD 2,026.00
    Until 5 Jan 21*
    Enrol now
    to attend
    Face to face
    15-16 Sep 2021
    Live webinar & Face-to-face (venue not yet confirmed)
    15-16 Sep 2021
    Live webinar &
    Face-to-face (venue not yet confirmed)
    GBP 1,099.00
    EUR 1,579.00
    USD 1,786.00
    Until 4 Aug 21*
    Enrol now
    to attend
    Live webinar
    GBP 1,299.00
    EUR 1,819.00
    USD 2,026.00
    Until 4 Aug 21*
    Enrol now
    to attend
    Face to face

    Learn more about our different live training formats.

    * Note the early booking discount cannot be combined with any other offers or promotional code

    Customised in-house training

    We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

    Contact us

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    Previous customers include...

    • Avillion LLP
    • Delim Cosmetics & Pharma s.r.l.
    • Geolab Pharmaceutical Industry
    • MHRA
    • Presspart
    • Presspart Manufacturing Ltd
    • QA Ltd
    • RPC Formatec GmbH
    • STADA Arzneimittel AG
    • Tabuk Pharmaceutical Research Co.
    • Teva Pharmaceuticals Ireland
    • Vectura

    I was hoping for further improvement of my understanding of the matter of inhalational drugs, especially MDI, and this expectation was fully met. The speakers had superb knowledge of the subject, vast experience and a great sense of humour.

    Robin Boehm, Team Leader Regulatory Submissions - New Products, STADA Arzneimittel AG, Sep 19

    In general good for content and presentation.

    Celestino Ronchi, President, Delim Cosmetics & Pharma s.r.l., Feb 19

    Very good course for those who has no previous experience in this Topic...Thanks to the organisers.

    Sami Qassim, Senior Vice President , Tabuk Pharmaceutical Research Co., Feb 19