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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

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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.

Benefits of attending:
  • 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

Inhalationlogo

RDDEurope2019

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

 

Media partners


 

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

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.

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.

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.

Book now

Book now

23-24 Jun 2021
Face-to-face, (venue not yet confirmed)
23-24 Jun 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 12 May 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

Learn more about our face-to-face and webinar 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

Previous customers include...

  • Actavis Inc
  • Aptar France
  • Astra Zeneca AB
  • BfArM
  • BORCULO DOMO INGREDIENTS UK LTD
  • Cad Middle East Pharmaceutical Industries
  • Cambridge Consultants Ltd
  • Copley Scientific Limited
  • EPIC THERA/MCKINNEY CONSULTING
  • Grunenthal GmbH
  • Harro Hoefliger Packaging Systems Ltd
  • Harro Hoefliger Verpackungsmaschinen GmbH
  • Hovione Farmaciência S.A.
  • Innovata plc
  • Insite Technology Limited
  • Medochemie Limited
  • Mundipharma Research Ltd
  • Neutec Inhaler San. Tic. A.S.
  • Next Breath
  • Novartis Pharma AG
  • Pharmaxis Ltd
  • Pharmazeutisches Institut der Universiat Kiel
  • RCC LTD
  • ROXANE LABS INC
  • Sanoffi Aventis Ltd
  • SANOFI AVENTIS R & D
  • Teva Pharmaceuticals Ireland
  • Ticona UK Ltd
  • Unilever R&D Vlaardingen
  • XSpray Microparticles AB

Very good organisation, time keeping, very valuable information delivered by speakers.

Waldemar Wiśniewski, Project Manager, Pulinno sp. z o.o., Jun 18

Well selected speakers, covering broad range.

Steffen Fredersdorf, Manager Clinical Program, Philip Morris International, Jun 18

Interesting, helpful, nice examples, informative! Offers good overview on DPI's. Many thanks!

Ina Brueckner, CMC Manager Medical Devices, Bayer Pharma AG, Jun 18

Thanks all of them, they share their valuable experience. All of the speakers are valuable people, they are the best in their jobs. Conference met my expectation.

Emre Kisasoz, Arven, Jun 18

I really thought it as well organised with good content, length of presentations and quality of speakers.

Mahmoud Farag, Scientific Business Development Manager, Qualicaps , Jun 17

In general, the course was very interesting and well organized

Berta Fernández Mollar, Senior Formulation Development Manager , Ferrer Internacional S. A., Jun 17

Very useful and relevant discussions

David Ward, Senior Formulation Scientist, Intertek, Jun 17

Overall I thought that the course was very useful, mainly due to the networking opportunities. The breadth of attendees was great to get wider conversations underway and broaden understanding. The scientific talks were generally excellent, and although some other talks were more around promoting products / services, the overall impression was positive and useful.

Richard Poole, Team Leader - Pharmaceutical Development, Vectura, Jun 17

One of the best courses I attended

Anna Giulia Balducci, Senior Scientist, Chiesi Limited, Jun 17

Great environment to stimulate debate! And challenge preconceptions and novel ideas

Richard Turner, Director Global Sales, Presspart Manufacturing Ltd, Jun 16

The course was very well organised, with a good selection of speakers and topics covered. I will certainly recommend future events to my colleagues.

Christopher Vernall, Business Development Director, Intertek Melbourn, Jun 16

Very good and useful update. Clear messages coming through.

Simon Strothers, Director, 3P Innovation Ltd, Jun 16

The course contained a good mix of speakers, the talks were current and relevant, the speakers responded well to lively discussions and challenges from the delegates. This is a good size meeting with questions freely asked and delegate interaction very high.

Tanya Church, Head of Laboratory, Chiesi Limited, Jun 16