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Nasal Drug Delivery Training Course

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

26-27 Apr 2022

& 4-5 Oct 2022

Book now

Details

Conference overview

What makes nasal delivery systems more challenging than solid dosage forms? How safe is nasal drug delivery? Are there such things as safe excipients? How does all this fit within the regulatory environment in Europe and the USA? How difficult is it to bring all these products to market?

This seminar seeks to explore these and many other questions in the field of nasal drug delivery, while reviewing interesting new data and innovative technologies. Leading industry authorities will cover all the relevant aspects of nasal physiology, anatomy, formulation strategies, the absorption of a variety of drugs in various phases of drug development, and new drugs entering the market. Nasal delivery to the sinuses will also be addressed as will the potential of delivering insulin to the brain. The comprehensive programme will include interesting case histories and provide ample opportunity to discuss all the key issues affecting this fast-growing industry.

Participants will benefit from:

  • An essential update on the very latest scientific developments and advances in technology
  • An unrivalled panel of international expert speakers who will share their valuable knowledge and insight
  • An excellent networking opportunity to build business relationships with fellow professionals

Media Partner

Inhalationlogo

Who should attend?

  • Managing directors
  • Medical directors
  • Heads of regulatory affairs
  • Quality assurance managers
  • Senior executives in research and development
  • Registration associates
  • Marketing managers
  • All departments that are already involved in nasal drug delivery or who wish to understand the potential of this alternative therapeutic route

Programme – day one

Nasal drugs to treat nasal disorders: a comprehensive review

  • Anatomy and physiology
  • Nasal disorders
  • Treatment options and future prospects to treat allergic and non-allergic rhinitis
  • CRS with and without nasal polyps

Discussion session

Nasal drug delivery challenges

  • Ideal attributes of a nasal spray formulation
  • Strategies to optimise deposition
  • Excipients to facilitate absorption
  • Technology for delivery and formulation characterisation

Effects of excipients in nasal powder formulations

  • Definition and characteristics of nasal powders
  • Formulation options for nasal powders
  • Excipients in nasal powders
  • (Side) effects of excipients in nasal powders
  • Delivery aspects of nasal powders

Discussion session

Advanced characterisation and formulation strategies for nasal drug delivery systems

  • Enhancing nasal absorption
  • Improving solubility and permeability
  • Successful treatment using the nasal route

In-vitro assessment of sinonasal drug delivery – appropriate as substitute for in-vivo studies?

  • Cadaver studies
  • Nasal cast studies
  • Computer simulation studies (CFD)

Discussion session

Characterisation of nasal devices for delivery of insulin to the brain

  • Nose to brain delivery
  • Nasal spray characterisation
  • Functional magnetic resonance imaging in human volunteers
  • Delivery of insulin to the brain by nasal administration

RetroNose: breakthrough technology for nasal drug delivery by oral route using an aerosol

  • RetroNose technology
  • Proof of concept with nebuliser
  • Proof of concept with pMDI
  • Differences of nasal deposition distribution between oral and nasal routes

Programme – day two

Review of nasal drug delivery devices

  • Trends in nasal delivery systems
  • Advances in device technologies
  • Nasal spray characteristics

Requirements concerning bioequivalence of nasal drug products from an authority’s point of view

  • Bioequivalence of nasal products
  • The evaluation of the monograph for nasal products in the European Pharmacopoeia will be outlined

Discussion session

Regulatory science for abridged nasal products

  • The guideline situation
  • PBE versus ABE
  • Elvis is alive: ‘Weight of evidence’

Human factors (HF) studies – a hype or a must-do?

  • Legal and regulatory guidelines covering human factors for pharmaceutical products
  • HF and risk management
  • HF and clinical trials
  • Generic combination products – ANDAs and HF
  • Questions and challenges

Discussion session

Development of three anatomical nasal models for more predictive in-vitro testing of nasal sprays

  • Construction of 20 nasal casts
  • Cast depositions for two nasal spray products
  • Correlations between cast geometry and nasal deposition
  • Approaches for selecting a small, medium and large nasal cast

Qualification of new nasal drug delivery systems for existing drugs

  • Formulation analysis
  • System and compatibility
  • Stability testing
  • Performance testing
  • Production line and efficiency optimisation

Nanotechnology for nasal drug delivery

  • Nanotechnology treatment methods
  • Design, characterisation and products
  • Application of nanoscale drug delivery systems

Discussion session

Concluding remarks

Presenters

Julie Suman (More...)

Dr. Julie D. Suman, R.Ph., Ph.D., is a co-founder and President of Next Breath, LLC, an incubator company located at the UMBC Technology Center. Next Breath, which incorporated in April 2002, is a contract research organisation dedicated to the development of nasal and inhalation delivery systems. She directs the contract research division that supports product development for North American and European clients in the pharmaceutical, biotechnology and medical device markets.

Julie holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a licensed Maryland pharmacist and a member of the Maryland Pharmacy Volunteer Corp. Julie has also been an affiliate assistant professor in the Department of Pharmaceutics at Virginia Commonwealth University since 2009.

Michael Benninger (More...)

Dr. Michael S. Benninger has been the Chairman of the Head and Neck Institute at The Cleveland Clinic since 2008. Previously he was the Chairman of the Department of Otolaryngology-Head and Neck Surgery at Henry Ford Health System in Detroit, Michigan. He has also been involved in Regional, National and International medical organizations. He served on the Board of Directors of the American Academy of Otolaryngology-Head and Neck Surgery for 12 years, having been a former Vice President and Chairman of the Board of Governors. Dr. Benninger is on the Board of Directors of the Voice Foundation and the International Association of Phonosurgeons, and has recently been on the Executive Council of the Triological Society. In addition to his numerous professional pursuits Dr. Benninger has authored 6 books, including his most recent books, “The Performer’s Voice” and “The Singer’s Voice”. He has written over 100 scientific articles, focusing primarily on voice care and laryngology, nasal and sinus disease and health care management. Dr. Benninger has also lectured extensively across the US and throughout the world.

Per Gisle Djupesland (More...)

Per G Djupesland, M.D., Ph.D. is the inventor of OptiNose’s patented, Breath Powered™ Bi-Directional™ nasal drug delivery technology. He has been Chief Scientific Officer of OptiNose since 2000 and is in charge of scientific efforts at OptiNose.
Dr. Djupesland is an Otorhinolaryngologist with a specialization in rhinology and more than 25 years of clinical experience in infectious diseases, epidemiology and surgery.
He has been Clinical Research Fellow at the Hospital for Sick Children and Toronto General in Toronto, Canada, primarily studying the role of Nitric Oxide in the upper airways.
He also authored more than 50 peer reviewed articles in international medical journals, and filed 35 patent families/patent applications.

Richard Featherstone (More...)

Richard Featherstone was one of the early pioneers of applying human factors research methods to combination products, having set up Medical Device Usability in 2008. Richard has been designing and conducting human factors studies for over 15 years, and his experience includes a wide range of drug delivery technologies including inhalers, auto-injectors, nasal sprays and associated devices such as tele-health systems. Following his most recent role as Research Director in Human Factors for Emergo by UL, Richard is now providing freelance consultancy and training services. Richard has advised some of the world’s largest pharmaceutical and medical device companies as well as small start-ups. Over 15 years of human factors work has meant that Richard has built a considerable body of knowledge of the regulatory requirements for usability testing, in particular in a European context.

Ben Forbes (More...)

Ben Forbes is a Professor of Pharmaceutics at King’s College London. He is currently the Head of the Pharmaceutics Teaching Section and the Drug Delivery Research Group of the Pharmaceutical Science Division. He has a B.Pharm from King’s College London (1987) and a Ph.D. in Drug Delivery from Strathclyde University (1995).

Profesor Forbes performed post-doctoral work in respiratory drug delivery at King’s College London from 1995 until he was appointed to the academic staff in 1997.

He is a registered pharmacist in the UK and serves on the committee of the Academy of Pharmaceutical Sciences focus group for Inhalation and the organising committee of the Drug Delivery to the Lung conference.

The research group led by Professor Forbes has nine members of academic staff working collaboratively on different aspects of inhaled drug delivery from particle engineering through to aerosol interaction with the respiratory epithelium and in vivo pharmacology.

Anders Fuglsang (More...)

Anders Fuglsang graduated in 1998 from the Royal Danish School of Pharmacy, Copenhagen, spending part of his studies at Leiden University, Netherlands. He was awarded his PhD in 2002 specialising in cardiovascular pharmacology. Following work as an Assistant Professor, he worked as a consultant for a number of Originator Pharmaceutical companies at a brand optimisation company in Copenhagen.

In 2005, he joined the Norwegian Medicines Agency as a Clinical Assessor and became Expert Advisor to the WHO and member of the Efficacy Working Party at the EM(E)A. He was Chair of the sub-group for Orally Inhaled Products and was also a member of the PK-subgroup. Other duties included provision of Expert Scientific Advice, GCP-inspection and -training, and responsibility for Assessor Training at the EM(E)A.

Through 2009 to September 2010, he was Clinical and Regulatory Strategy Manager at a world leading generic company. He has now established his own pharmaceutical consultancy. Clients include the World Health Organization, generic companies, innovators, drug delivery firms and investment banks.
He is the author of approximately 30 papers in the fields of Generics, Genetics and Pharmacology, and is a reviewer for some 15+ international journals including Science, Trends in Genetics and Drug Discovery Today.

Tom Grinnan (More...)

Thomas Grinnan, Vice President, Sales & Marketing, Healthcare, Silgan Dispensing Systems, has worked in the pharmaceutical industry for more than 28 years as an executive, innovator, consultant and business development specialist. A biologist, he began his career in the Healthcare practice of Markowitz & McNaughton, Inc., a strategy consulting firm, working closely with pharmaceutical and medical device companies. After receiving his MBA, he began a long career with Mebane Packaging, a healthcare packaging company, and its antecedents Westvaco and MeadWestvaco.

At MeadWestvaco, Tom held various leadership roles in the Patient Adherence and Healthcare Packaging business, leading European sales & marketing, global clinical trial packaging, as well as business development and innovation. After MeadWestvaco (subsequently renamed Westrock), Tom joined Silgan Dispensing Systems, aspin-off specializing in the supply of pump and liquid dispensing solutions. Silgan DispensingSystems is a leading partner to the pharmaceutical industry, supplying pumps and dispensing systems for nasal, ophthalmic, topical, oral and otic applications. Tom received his BA fromthe University of Virginia and his MBA from the University of North Carolina, Chapel Hill.

Cornelia Nopitsch-Mai (More...)

Dr Cornelia Nopitsch-Mai studied pharmacy at the Free University Berlin and graduated in pharmaceutical biology. She is scientist at the Federal Institute for Drugs and Medical Devices in the assessment of the quality of the dossier since 1991.

She is experienced in the assessment of pharmaceutical dossiers for marketing authorisation applications of medicinal products. She has broad knowledge of the national and EU regulations medicinal products as well as for the corresponding EU guidelines and the European Pharmacopoeia. Since 2000 she is assessor for the Certification Procedure (EDQM) in Strasbourg. She was member of the Technical Advisory Board (TAB) from 2001 to 2010. She was chairperson of the TAB from 2005 to 2010. She was member of the Quality Working Party from October 2007 to February 2011. Since 2014 she is member of the INH Working Party.

Regina Scherließ (More...)

Prof. Dr. Regina Scherließ (*1979) is a professor for Pharmaceutics and Biopharmaceutics, director of the section Pharmacy and chair of the Department of Pharmaceutics at Kiel University, Germany. As such she leads the research unit in Pharmaceutics and is responsible for all teaching in Pharmaceutics and Biopharmaceutics at Kiel University. She is a pharmacist and received her Dr. rer. nat. (doctor of natural sciences) in 2008 for a work on “Formulation of inhalation combination products by co-precipitation”. In 2015 she finished her “habilitation” working on “Mucosal vaccination via the respiratory tract”. During her academic education she had research stays in Denmark, the US, New Zealand and Australia. She also received several young researcher awards including The Pat Burnell New Investigator Award 2010 of the Aerosol Society and is member of the DDL scientific committee (since 2015). Her research interests include disperse systems and nanoparticles, stabilization of biomolecules in spray drying and formulations for mucosal vaccination with a focus on respiratory (nasal and pulmonary) dry powder delivery.

Book now

Book now

26-27 Apr 2022
Live webinar
26-27 Apr 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 22 Mar 22*
Enrol now
to attend
Live webinar
4-5 Oct 2022
Face-to-face, (venue not yet confirmed)
4-5 Oct 2022
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 30 Aug 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days 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

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

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.

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Previous customers include...

  • BALDA MEDICAL GMBH
  • Bespak Europe Ltd
  • BOC Medical
  • Boehringer Ingelheim Pharma GmbH & Co. KG
  • CENTER GENETIC ENG. & BIOTECHNOLOGY
  • Charles River Laboratories
  • CLINITRIALS BIO RESEARCH LTD
  • Dermal Laboratories Ltd
  • dne pharma AS
  • EBEWE Neuro Pharma GmbH
  • Fortitude
  • Indivior Plc
  • Indivior UK Limited
  • Intranasal technology Inc
  • M+P Pharma AG
  • Nemera La Verpilliere
  • OM Pharma SA
  • OPTINOSE U K LTD
  • Orexo AB
  • PERLOS LTD
  • Presspart
  • SOCRATEC R&D GmbH
  • Teijin Pharma Limited
  • TEL AVIV UNIVERSITY
  • University of Gent
  • University of York
  • Upperton Ltd
  • Vertex Pharmaceuticals
  • VIRSOL
  • Zafgen

I was able to take away relevant information from each presentation. Great networking and worth the cost and time of international travel.

Michelle Sparks, Head of Product Development, Zafgen, Apr 19

Well organised, good agenda!

Michiharu Kageyama, Manager, Teijin Pharma Limited, Apr 18

The speakers were all very well spoken and gave a good overview of the background to their research/product before going into detail. It was a very well organised programme with a variety of interesting topics delivered by experts within the field.

Gillian Hutcheon, Reader, Liverpool John Moores University, Apr 18

The speakers were enthusiastic and highly knowledgeable and there was plenty of opportunity for discussion and a really good in-depth exploration of the subject. Excellent.

Nicola Hardman, Jenson R+ Ltd, Apr 17

A great collection of knowledgable speakers.

Matthew Burton, Jenson R+ Ltd, Apr 17