Information from Recent Meetings
- The IPAC-RS Conference “Doing the Right Thing” in the Changing Culture of Design and Development of Inhalation and Nasal Drug Products: Science, Quality and Patient-Focus on 22-24 September 2008, included: (1) constructive dialogue between pharmaceutical and device industry, regulators and other stakeholders, (2) consideration of the potential for environmentally responsible design and manufacturing of OINDPs, (3) examples of applying Quality-by-Design and Pharmaceutical Development principles to OINDP; and (4) patient perspectives. Over 170 people from 48 companies and five regulatory agencies attended the Conference. Presentations are posted at: www.ipacrs.com/ipac2008.html. Posters are available at: www.ipacrs.com/posters.html.
1Q 2009 FDA Public Hearings/Meetings
- Tentative Schedule of 2009 FDA Advisory Committee meetings: http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-451.pdf
- FDA Unique Device Identification Public Workshop on 12 February 2009 in Gaithersburg, MD. http://www.fda.gov/cdrh/meetings/021209workshop/
- FDA Science Board Meeting will meet on 24 February 2009 in Gaithersburg, MD (http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-2797.pdf). The Science Board will hear about and discuss updates from the FDA on the continued assessment of Bisphenol A (BPA) in FDA-regulated products. The Science Board will hear about the plans for the following: (1) The review of FDA Center's science programs, (2) the review of each Center's projects within scientific priority areas, and (3) the handling of biospecimens used for genomic and proteomic analyses. The Science Board will also hear updates from two working groups on economically motivated adulteration of FDA-regulated products and rapid detection of Salmonella in foods. Background information will be available at: http://www.fda.gov/ohrms/dockets/ac/oc09.html#ScienceBoard
- FDA Risk Communication Advisory Committee meeting on 26-27 February 2009 in Washington, DC. On both days there will be a discussion of different types of prescription drug information currently available to patients in the form of Medicating Guides, Patient Package Inserts (PPIs), and Consumer Medication Information (CMI) (http://www.fda.gov/oc/advisory/accalendar/2009/OCRCACMtg02262709.html).
- FDA is hosting a public workshop Improving Endpoints, Improving Care: Alpha-1 Antitrypsin Augmentation Therapy and Clinical Trials on 23-24 March 2009 in Bethesda, MD (http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-2905.pdf). The purpose of the public workshop is to identify the most useful clinical trial endpoints and surrogate markers for Alpha-1 antitrypsin (AAT) augmentation therapy. FDA, Alpha-1 Foundation, and the Department of Health and Human Services, Office of Public Health and Science are convening this workshop to facilitate the design of future clinical trials intended to establish clinical efficacy of AAT products. The public workshop will feature presentations and panel discussions led by experts from academic institutions, government, and industry. Transcripts from the meeting will be available at: http://www.fda.gov/cber/minutes/workshopmin.htm.
- FDA is holding a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), the American College of Chest Physicians (ACCP), the Society of Critical Care Medicine (SCCM), and the American Thoracic Society (ATS) regarding scientific issues in clinical trial design for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). The public workshop is intended to provide information about, and gain perspective from, health care providers, academia, and industry on various aspects of antimicrobial drug development for HAP and VAP, including diagnosis of HAP and VAP, effect of antimicrobial treatment for HAP and VAP, endpoints for trials of HAP and VAP, and statistical issues in analysis of results of trials in HAP and VAP. The input from the public workshop will help in developing topics for further discussion. The public workshop will be held on 31 March – 1 April 2009 in Silver Spring, Maryland. (http://www.fda.gov/cder/meeting/hap_vap.htm)
- FDA CDER Small Business Assistance is hosting a public workshop Small Pharmaceutical Business Assistance Educational Forum on 23 April 2009 in Jamaica, NY. The workshop is to provide information to small pharmaceutical businesses about FDA's premarket requirements, good manufacturing practices, OTC and generic drug issues. (http://www.fda.gov/cder/meeting/small_business_2009.pdf).
Other Upcoming Meetings
- 13th Annual Drug Delivery Partnerships 21-23 January 2009 in Las Vega, Nevada.(http://www.iirusa.com/ddp/welcome.xml)
- European Continuing Education College: Properties and Processing of Pharmaceutical Powders 2-4 February 2009 in London, UK. (http://www.ecec.co.uk/)
- IMPURITIES FORUM 2009: Strategic Identification, Detection, Control and Methods to Ensure Regulatory Compliance for APIs and Drug Products on 5-6 March 2009 in Philadelphia, PA. (http://www.pharmaedresources.com/brochures/ImpuritiesForum2009.pdf) • APS Inhalation2009: The changing face of inhalation – fit for the future. March 23-25, 2009. University of Nottingham, UK. (http://www.apsgb.co.uk/events/20090323/DownloadProgramme.asp)
- Society of Toxicology 2009 Conference. 15-19 March, Baltimore Convention Center, Baltimore, MD. (http://www.toxicology.org/AI/MEET/AM2009/index.asp).
- Aerosol School sponsored by Firestone Research Aerosol Laboratory at St Joseph’s Healthcare, McMaster University and ISAM on 16-17 April 2009 in Hamilton, Ontario, Canada. Aerosol School is an intensive two day curriculum designed to provide the didactic background and practical handson experience to quantify and characterize medical aerosols. Upon completion of the program, participants should understand the measurements and techniques utilized in commercial pharmaceutical and biotech laboratories as well as academic research. The perfect primer for anyone interested in measurements of medical aerosols, whether for industry or clinical research. Registration will be limited to the first 20 participants to assure good hands-on experience. For further information please contact: Myrna Dolovich at email@example.com or call 905 522 1155 x33597.
- SMi’s 5th Annual conference on Asthma and COPD 20-21 April 2009 in London, UK. (http://www.smi-online.co.uk/events/overview.asp?is=4&ref=3054).
- 2009 PDA Annual Meeting 20-24 April 2009 in Las Vegas, Nevada. (http://www.pda.org/annual2009)
- The 3rd Annual FDA/DIA Statistics Forum on 26-29 April 2009 in Arlington, VA (http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=18027&eventType=Meeting)
- 17th ISAM Congress 10-14 May 2009 in Monterey, California. (http://www.isam2009.com/main.cfm?cid=1333)
- Rapra Leachables and Extractables for Pharmaceutical Products. 12-14 May 2009 in Barcelona, Spain (http://www.rapra.net/products_and_services/Conferences/Leachables_and_Extractables_for_Pharmaceutical_Products.asp?).
- RDD Europe 2009 19-22 May 2009 in Lisbon, Portugal. (http://www.rddonline.com/rdd/rdd.php?id=4).
- European Continuing Education College: Pharmaceutical Aerosols and Dry Powder Inhalation Systems 3-5 June 2009 in London, UK (http://www.ecec.co.uk/).
- FDA/AAPS: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit on 10-12 June in Rockville, MD (http://ce.pharmacy.wisc.edu/courseinfo/fdauwqbd/#committee)
- Inhalation Aerosol Technology Workshop on 15-17 June 2009 Pharmacy Learning Center, University of Maryland in Baltimore, Maryland. Optional Laboratory Session 18 June. The course provides a unique and detailed assessment of modern inhalation drug delivery. Descriptions of formulation, design considerations, manufacturing techniques and evaluation procedures for pressurized inhalers, dry powder devices and nebulizers are reinforced with demonstrations. Novel technologies are summarized and critiqued. Patient, regulatory and marketing considerations for inhalation systems are emphasized. (http://www.pharmacy.umaryland.edu/faculty/rdalby/IATW%20Web%20Pages/iatw.htm). For more information contact: Dr. Richard Dalby, +1 (410) 706 3245; firstname.lastname@example.org
- 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference on 15-19 June 2009 in Shaghai, China. The Conference is jointly sponsored by PDA and the Shanghai Municipal FDA (SHFDA) as a result of a memorandum of understanding signed in September 2008. Conference sessions will be led by regulatory speakers from the US FDA and the SHFDA, and industry speakers from the United States and China. Topics of discussion will include the global regulatory environment and the integrity of the Pharmaceutical Ingredient Supply Chain. (http://www.pda.org/asiapacific)
- 2009 PDA/FDA Joint Regulatory Conference on 14-18 September 2009 in Washington, DC. (http://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/2009-PDAFDA-Joint-Regulatory-Conference.aspx)
- The IPAC-RS Supplier Quality Control Working Group, an initiative including representatives from OINDP manufacturers and device component suppliers, continues to highlight its GMP Guideline for Suppliers of OINDP Components. In addition, FDA and Health Canada have invited the Working Group to present a training session on the Guideline. These training sessions will be held in 2Q 2009.
The IPAC-RS GMP Guideline, which incorporates the PS 9000 and ISO 9001 Guidelines, addresses those areas of GMP critical to OINDP that are not sufficiently addressed by existing quality Guidelines. The Guideline includes topics such as change control, cleaning, and extractables. The Guideline is available for purchase at http://www.ipacrs.com/supplier_quality.html. The Guideline was developed in an effort to help build quality into OINDP; encourage quality through design rather than through testing; promote quality assessment early in the supply chain; and provide OINDP suppliers and manufacturers with harmonized standards for OINDP component quality. The Working Group has organized several workshops on the Guideline. In addition, representatives of the Working Group have had several discussions with regulators about the experience in developing the Guideline as well as how the industry and suppliers are using and implementing it. FDA indicated that use of the Guideline by a manufacturer would inspire confidence and would be construed positively by an inspector