Key annual conference for Pharmaceutical and Medical Device Professionals in the DPI market.
The second generation of DPIs have become either established on the market or are a signi cant way along
the approval process. These have been a great success story in improving inhaled drug delivery. However, we now have to tackle the technical and regulatory issues with ‘generic’ inhalers and their approval. The development of triple therapies is well underway, these bring about their own challenges of formulation and bioequivalence. Amazingly, new DPIs are still being created, with some moving in to development programs. Furthermore, one of the areas where much study and recent guidance has been applied is in considering the patient use, compliance and human factors associated with DPIs. These linked topics are creating a whole new area that requires better understanding during product development and associated studies.
This conference aims to: address many of the issues around generic inhalers, provide case studies of bioequivalence testing, focus on the difficult formulation challenges and the strategies used so that they may be overcome, and to discuss in-depth patient and human factor issues when developing a DPI to gain regulatory approval.
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If you would like to contribute a presentation at the 2019 event please contact andrea.james@management-forum.co.uk
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Exhibitors
Those involved in
THIS IS THE 2018 PROGRAMME THE 2019 PROGRAMME WILL BE AVAILABLE IN DUE COURSE
A personalised medicine approach to the design of dry powder inhalers
Novel DPI Delivery Platforms
Experiments with Dry Powder Inhalers
In-vivo extra fine particles
High dose delivery utilising a DPI
The iSPERSETM platform
The next generation combinations
Connected DPI devices
THIS IS THE 2018 PROGRAMME THE 2019 PROGRAMME WILL BE AVAILABLE IN DUE COURSE
New medical device and combination product regulations on DPI development
Human factors in the design of DPIs
Challenges with generics
Bioequivalence research with the FDA
Dissolution and beyond: the use of advanced characterisation tools for demonstrating pharmaceutical equivalence of orally inhaled drug products
Get it right: 100% in-line verification of dosed mass in inhalation devices
The current good manufacturing practices (cGMP) requirements become more demanding and statistical in-process control (IPC) as well as process analytical technology (PAT), these are key components of quality control in a pharmaceutical manufacturing environment. The lling of powder for inhalation into blister or other receptacles for pre-metered powder is a challenge due to low ll weight and poor powder ow-ability. New technologies are utilizing different control systems to ensure consistent quality of the products and to reduce waste & overall costs.
Developing inhaled Lactose formulations
Dr Paul Royall
Helen Muirhead
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.
| 19-20 Jun 2019 | |||
| 19-20 Jun 2019 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
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“Very good organisation, time keeping, very valuable information delivered by speakers. ”
Waldemar Wiśniewski, Project Manager, Pulinno sp. z o.o.
“Well selected speakers, covering broad range.”
Steffen Fredersdorf, Manager Clinical Program, Philip Morris International
“Interesting, helpful, nice examples, informative! Offers good overview on DPI's. Many thanks! ”
Ina Brueckner, CMC Manager Medical Devices, Bayer Pharma AG
“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
“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
“I really thought it as well organised with good content, length of presentations and quality of speakers.”
Mahmoud Farag, Scientific Business Development Manager, Qualicaps
“One of the best courses I attended”
Anna Giulia Balducci, Senior Scientist, Chiesi Limited
“In general, the course was very interesting and well organized”
Berta Fernández Mollar, Formulation Manager , Ferrer Internacional S. A.
“Very useful and relevant discussions”
David Ward, Senior Formulation Scientist, Intertek
“Great environment to stimulate debate! And challenge preconceptions and novel ideas”
Richard Turner, Director, Presspart Manufacturing Ltd
“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 Manager, Intertek
“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
“Very good and useful update. Clear messages coming through.”
Simon Strothers, Director, 3P Innovation Ltd