Issue link: http://www.e-digitaleditions.com/i/880535
Recent news items on activities of regulatory agencies such as the US Food and Drug Administration, European Medicines Agency, Health Canada and others 6 OctOber 2017 Inhalation ments in the area of respiratory drug delivery. • e RDD VCU Peter R. Byron Graduate Student Award, given to a student who presents the highest-quality research at the conference. • Peer-reviewed proceedings in print or electronic format to all registrants. • Numerous networking oppor- tunities to meet new scientists and business professionals. Get involved No matter which RDD meeting you decide to attend, our goal re- mains to equip academic, indus- try and government scientists and business professionals with the information and skills needed to optimize the performance of their organizations to best serve the needs of patients and customers. We invite you to become involved as a delegate, presenter, exhibitor and/or sponsor as we continue our 30-year legacy of providing excellent meeting value for all in- dividuals and organizations active in the development of inhaled and nasal products. Learn more at www.rddonline.com. RegulatoRy and compendial news FDA, EMA and EC sign new confidentiality commitment SILVER SPRING, MARY- LAND—Pharma Times reports that the US Food and Drug Ad- ministration (FDA) can now share non-public and commer- cially confidential information, including trade secrets relating to medicines inspections, with EU regulators because the FDA, Eu- ropean Medicines Agency (EMA) and the European Commission (EC) have signed a new confiden- tiality commitment. Transatlantic confidentiality ar- rangements that allow for the ex- change of confidential informa- tion as part of regulatory and scientific processes have been in place since 2003 but complete ex- change of data, including full in- spection reports, was not possible until now. e new commitment will allow regulators to make deci- sions based on findings in each other's inspection reports and to make better use of their inspec- tion resources to focus on manu- facturing sites of higher risk. Pharma Times indicated the EMA stated the agreement is "a milestone in the ongoing implementation of the mutual recognition of inspec- tions of medicine manufacturers," and aims to strengthen ties between the EU and US and will "ultimate- ly contribute to a more efficient use of inspection resources by regula- tors for the protection of human and animal health." Quali-V ® -I capsules for inhaled drug delivery Reduced Powder Adhesion Strict Microbiological Control Better Aerosolization Inner Surface Control Superior Puncturing Properties WHAT WE DO WHAT WE ARE CAPSULES ARE THE VERY ESSENCE OF QUALICAPS ® As such, we are uniquely positioned to provide a capsule designed and manufactured for optimal performance in Dry Powder Inhalers REDISCOVER QUALICAPS ® at www.qualicaps.com