The session on “Changing Regulations in Europe” attracted a great deal of interest as well. In her talk titled, “New European Medical Device Regulations: Implications for Orally Inhaled and Nasal Drug Products,” consultant Maria Donawa discussed the imminent publication of the new Medical Device Regulations (MDR) in the EU. The MDR will be much longer and more complex than the existing Medical Device Directive (MDD) it will replace, Donawa noted, and will change the way that non-active inhalation devices will be classified. She also described ways in which the new regulations will impact all inhalation devices.
David Jefferys of Eisai discussed the consequences of the UK Brexit vote for inhaled drug developers, noting that the UK’s pharmaceutical system is more integrated into the EU than any other system. Some of the major questions he addressed included the future location of the European Medicines Agency, the role of the MHRA, how drugs will move between the UK and Europe, and clinical trial and pharmacovigilence procedures.
A range of topics was addressed in the Posters on the Podium session, which includes presentations by the authors of the top five posters submitted for RDD Europe 2017 as determined by the selection committee. Those posters included:
- “High-efficiency Delivery Of Aerosols Via An Infant Nasal Cannula,” Susan Boc, Virginia Commonwealth University
- “Proof of Concept of the Vitrocell Dry Powder Chamber: A New In Vitro Test System for the Controlled Deposition of Aerosol Formulations,” Marius Hittinger, PharmBio Tec
- “Validating a Realistic Physical Airway Model to Investigate In Vitro Drug Deposition, Dissolution, and Epithelial Transport of Orally Inhaled Products,” Bao Huynh, Woolcock Institute of Medical Research
- “Comparison of Three Aqueous Aerosol Inhalation Devices for Delivering Anti-Tuberculosis Bacteriophage D29,” Nicholas Carrigy, University of Alberta
- “Environmental Assessment of Metered Dose Inhaler Propellant: Potential For a Reduced Carbon Footprint Alternative,” Adisa Azapagic, University of Manchester
Following the session, the 2017 VCU RDD Peter R. Byron Graduate Student Award was presented to Cordula Weiss of the Waterford Institute of Technology for her poster titled “Synthesis and Materials Characterization of Beclomethasone Dipropionate (BDP) Solvates as Precursors for Anhydrous BDP Particles for Dry Powder Formulations.” The award, which is funded by an endowment at Virginia Commonwealth University, will reimburse Weiss for her registration and meeting expenses.