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News & Notes

  • The Envelope, Please!

    by: Rebecca Stauffer, PDA | Apr 30, 2018
    Honor Award Winners

    Each year, PDA recognizes members whose contributions have helped the Association fulfill its mission at the Awards Dinner, held during the Annual Meeting. PDA congratulates each winner for their service to the Association.

    Honorary Membership

    This is PDA’s most prestigious award, conferring lifetime membership benefits to the recipient. The award has traditionally been given in recognition of long service significant in nature to PDA and requires unanimous approval from the Board of Directors.

    • Rich Levy, PhD

    Gordon Personeus Award

    Presented in memory of the late Gordon Personeus, past PDA President and longtime volunteer, this award is intended to honor a PDA member, other than a Board member, for long-term acts or contributions that are of noteworthy or special importance to PDA.

    • Michael De Felippis, PhD
    • Janeen Skutnik-Wilkinson

    Frederick J. Carleton Award

    This award is presented as a tribute to lifetime contributor, past President, past Executive Director, and Honorary Member Frederick J. Carleton, and is designated for past or present Board members.

    • Gabriele Gori
    • Christopher Smalley, PhD

    Martin VanTrieste Pharmaceutical Science Award

    Established in honor of long-time contributor and Chair Martin VanTrieste, this award is given annually for outstanding contributions to the advancement of pharmaceutical science.

    • Michael Miller, PhD

    Michael S. Korczynski Award

    An award established in recognition of contributions made toward the development of PDA’s international activities by Michael S. Korczynski, PhD.

    • Ursula Busse, PhD
    • Hirohito Katayama, PhD

    Edward Smith Packaging Science Award

    In honor of long-time volunteer Edward Smith, who led PDA’s packaging science activities, this award is given in recognition of extraordinary contributions to PDA and the packaging science.

    • Mathias Romacker

    Distinguished Service Appreciation Award

    This award is given in recognition of special acts, contributions or services that have promoted the success and strength of PDA.

    • Patricia Hughes, PhD
    • Maria Jacobs, PhD
    • Stephan Krause, PhD
    • Hanns-Christian Mahler, PhD
    • Roman Mathaes, PhD
    • Tsuguo Sasaki, PhD

    James P. Agalloco Award

    The James P. Agalloco Award is presented annually to the PDA faculty member who exemplifies outstanding performance in education. The award is named for James P. Agalloco, in honor of his work in developing the PDA Education program.

  • Lee Leichter
  • Frederick D. Simon Award

    The Frederick D. Simon Award is presented annually for the best paper published in the PDA Journal of Pharmaceutical Science and Technology. This award is named in honor of the late Frederick D. Simon, a former PDA Director of Scientific Affairs. This year’s award went to three recipients for their article, “Particulate Generation Mechanisms duringBulk Filling and Mitigation via New Glass Vial,” which was published in the September/October 2017 issue of the PDA Journal.

    • Christopher Timmons
    • Chi Yuen Liu
    • Stefan Merkle

    Distinguished Editor/Author Award

    This award recognizes the author or editor selected by PDA members for their contribution to PDA’s technical books. This year’s award went to the author of the book, Method Development andValidation for the Pharmaceutical Microbiologist.

    • Crystal Booth

    PDA Europe Service Appreciation Award

    This award is presented annually for special acts, contributions or services that have contributed to the success and strength of PDA’s European activities.

    • Siegfried Schmitt, PhD

    Service Appreciation Award

    This award is presented annually for special acts, contributions or services.

    • Deborah Autor
    • Hal Baseman
    • Ursula Busse, PhD
    • Joyce Bloomfield
    • Stephan Rönninger, PhD
    • Maureen Hertog
    • Keith Koehler
    • Sanjit Singh Lamba
    • Jason Mattis
    • John Michael Morris
    • Kenneth Paddock
    • Leticia Quinones, PhD

    President’s Award

    This award recognizes a PDA staff member, other than senior staff, whose exemplary performance has contributed to PDA’s success during the previous year.

    • Emily Lyons
    • Katie Ruiz
  • PDA Welcomes Tina Morris

    by: Walter Morris, PDA | Apr 30, 2018

    Richard Levy, PhD, Sr. VP of Scientific and Regulatory Affairs Stepping Down After 13 Years

    PDA is pleased to welcome Tina Morris, PhD, as the Association’s new Vice President of Scientific and Regulatory Affairs. Currently, she serves as Senior Vice President of Compendial Sciences at the U.S. Pharmacopeia, with whom she has worked for 15 years. She will join the PDA family effective June 4.

    Tina Morris
    Tina Morris

    In her new role, Morris will oversee PDA’s scientific and regulatory affairs activities, which include industry-leading technical reports, the newly launched standards-development program through the American National Standards Institute (ANSI), regulatory commenting, and overseeing PDA’s four technical/regulatory advisory boards.

    “Dr. Morris has strong leadership capabilities in a volunteer-based organization that we believe are essential to PDA’s efforts to continue PDA’s legacy of leadership in bio/pharmaceutical science,” said Richard Johnson, President and CEO, PDA.

    Morris began her career at USP as a Senior Scientific Liaison in 2003, and saw her responsibilities grow each year before becoming Senior Vice President in 2015. Prior to USP, she worked for Human Genome Sciences, Inc. and at Ciphergen Biosystems, Inc. She received her PhD in molecular virology from the Medical University of Luebeck, Germany and a Bachelor of Science and Master of Science in biology from the Carl von Ossietzky University in Oldenburg, Germany.

    Richard Levy, PhD, PDA’s outgoing Senior Vice President of Scientific and Regulatory Affairs, announced his retirement earlier this year after 13 years in the role. Among his many accomplishments in the role, Levy oversaw a marked increase in the number of technical documents published annually, the conversion of the PDA Journal of Pharmaceutical Science and Technology from a print to an online-only publication, and the growth in the number of staff in the Scientific and Regulatory Affairs department to better support the efforts of member volunteers. He will take on the role of Editor of the PDA Journal of Pharmaceutical Science andTechnology on May 21.

    Richard Levy

    “Dr. Levy’s many contributions to PDA, both as a volunteer for many years and as part of the staff since 2005, are numerous,” said Johnson. “He was most instrumental in ramping our technical activities to a level higher than any time in our history. We look forward to working with Dr. Levy as the editor of the Journal for many years to come.”

  • Check Out the New and Improved PDA Connect

    by: Rebecca Stauffer, PDA | Apr 02, 2018

    On Feb. 19, PDA unveiled an updated version of PDA Connect SM, our online networking community, based on user feedback.

    If you have not already, log in to PDA ConnectSM to explore new and improved features, such as:

    • Mobile-friendly design
    • Intuitive navigation
    • Community-oriented layout
    • Popular “newsfeed” format

    You can access the updated version of PDA Connect SM with the same login credentials you currently use to log into your PDA account.

    PDA ConnectSM provides a forum for PDA members around the world to share information, advice and best practices on a wide variety of important topics.

  • Global Pharmacopeial Reps to Speak in May

    by: Rebecca Stauffer, PDA | Apr 02, 2018

    Representatives from pharmacopeias and regulatory agencies across the globe are scheduled to speak at the PDA Europe Pharmacopoeia Conference scheduled for May 29–30 in Vienna. PDA is honored to welcome speakers from the following pharmacopeias and agencies:

    • European Directorate for the Quality of Medicines & Health - Care, EDQM (European Pharmacopoeia)
    • U.S. Pharmacopeial Convention
    • Japan Pharmaceuticals and Medical Devices Agency
    • Russian Ministry of Health
    • Eurasian Economic Union Pharmacopeia Committee
    • Indian Pharmaceutical Commission
    • Brazil Pharmacopeia
    • Ghana FDA
    • WHO (International Pharmacopoeia)
    • MHRA
    • British Pharmacopoeia Commission

    Learn more about the Pharmacopoeia Conference.

  • Announcing the PDA Letter Article of the Year

    by: Rebecca Stauffer, PDA | Apr 02, 2018
    Frithjof Holtz

    PDA and the editors of the PDA Letter have launched the Article of the Year recognition. Congratulations go to Frithjof Holtz of Merck KGaA, Darmstadt, Ger - many. His January 2017 article, “Formalizing a Risk Assessment for Excipients,” is the PDA Letter Article of the Year for 2017. The article is currently available on the PDA Letter website.

    Holtz is working with PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB) on a joint technical report on risk assessments for excipients in partnership with IPEC.

  • Nominate a Candidate for the PDA Board of Directors

    by: Rebecca Stauffer, PDA | Feb 26, 2018

    PDA’s Nominating Committee seeks member recommendations for nominees of candidates to fulfill Board of Director positions for the 2019–2021 term. Nominees must be current PDA members in good standing. This year’s committee is chaired by Martin VanTrieste, Immediate Past Chair of the Board of Directors.

    If you are interested in being considered or want to recommend someone, send a recommendation (including full name, contact information and rationale for nomination) by email or by regular mail to PDA Global Headquarters, Bethesda Towers, Suite 600, 4350 East West Highway, Bethesda, MD, 20814, USA, Attention: Nominating Committee. Please include any supporting information, which may make it easier for the Nominating Committee to evaluate your recommendation. Nominations are due May 15.

    If you have any questions, feel free to contact PDA President Richard Johnson or Martin VanTrieste.

  • INTERPHEX Roundtables Address PUPSIT, Big Data

    by: Rebecca Stauffer, PDA | Feb 26, 2018

    PDA is once again the Premier Association Sponsor for the INTERPHEX show scheduled for April 17–19 in New York City.

    In this role, PDA will be hosting three informational roundtables as part of the INTERPHEX Technical Conference. Here, experts will share the latest thinking on key topics, including:

    • State of the Industry Practice for Pre- Use, Post-Sterilization Integrity Testing (PUPSIT), Tuesday, April 17, 10:30 a.m. – 11:30 a.m.
    • Technology and Process for Cell and Gene Therapy Manufacturing, Wednesday, April 18, 2 p.m. – 3 p.m.
    • Use of Big Data for Predictive Process Control, Thursday, April 19, 10:30 a.m. – 11:30 a.m.

    To view an agenda for the show and to register, please visit the INTERPHEX website.

  • PDA Remembers Edwin Rivera-Martinez

    by: Rebecca Stauffer, PDA | Jan 29, 2018

    PDA was saddened to learn of the passing of longtime volunteer Edwin Rivera-Martinez on Dec. 28. Edwin was a major part of PDA’s family. Many of us remember how he could spin a good yarn and capture an audience with his enthralling presentations. He was heavily involved in supporting efforts to ensure the supply chain around the world, including the Asia-Pacific region.

    Edwin made many contributions as a PDA volunteer. From 2012–2017 he was part of the Regulatory Affairs and Quality Advisory Board (RAQAB). As part of this role, he also served as the RAQAB liaison to the PDA Letter Editorial Committee. He also served on the program planning committees for PDA’s supply chain conferences/workshops in 2010, 2011 and 2013 and was a speaker and instructor at a Japan Chapter Annual Meeting. Edwin also spoke at a 2009 PDA meeting in Europe on the supply chain of pharmaceutical ingredients. Additionally, he was an active contributor to the Quality Metrics Task Force. His significant contributions to PDA are part of his legacy that will remain with us.

    His extensive industry experience served to benefit PDA and its members. He was proud of his many years of work at the U.S. FDA where he was an investigator. While at FDA, he was the driving force behind ICH Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. As part of CDER, he was actively involved in many initiatives, training programs and conferences with PDA, where he contributed to communicating the Agency’s expectations and industry practice on important technical and regulatory matters.

    While working at Sanofi over the past six years, Edwin was always fully dedicated to quality, compliance and patient safety and was a strong contributor to the company’s quality culture journey. He was a true gentleman whose kindness was unanimously recognized by many Sanofi colleagues across the world.

    Edwin will be sorely missed by PDA. His passion for ensuring safe medicines was infectious and the Association plans to carry on this legacy.

  • Global Regulators to Address Packaging Concerns

    by: Rebecca Stauffer, PDA | Jan 29, 2018

    The following three regulators will offer regulatory perspectives on packaging issues at the PDA Europe Parenteral Packaging conference, Feb. 27, in the opening plenary session:

    • Andrew Hopkins, MHRA, will speak on container closure integrity testing and Annex 1, 9:15 a.m.
    • Umit Kartoglu, WHO, will speak on secondary packaging considerations, 9:45 a.m.
    • Charudharshini Srinivasan, U.S. FDA, will speak on risk-based approaches to assessing pharmaceutical packaging for parenterals, 10:15 a.m.

    For more information, visit the meeting website.

  • PDA Family Continues to Grow

    by: Rebecca Stauffer, PDA | Jan 29, 2018

    PDA is excited to have some new folks join the PDA family, both in the United States and Europe.

    • Glenn Wright, has joined PDA effective Jan. 1 in the role of Business Development Fellow. Glenn has been a longtime PDA volunteer and was a member of the Board of Directors for many years.
    • Lindsey Navin, Senior Marketing Coordinator, joined PDA Oct. 23 and brings with her a broad background in marketing, having worked in a number of industries, including academia, communications and healthcare.
    • Annette Bacchus, Manager of Programs, joined PDA on January 22. Most recently she was Senior Manager of Industry Relations at the American Academy of Otolaryngology- Head and Neck Surgery.
    • Teresa Schubach, Manager Programs and Events, joined the PDA Europe office in Berlin on January 15. She has a degree from Johann Wolfgang Goethe University in Frankfurt where she majored in Biology.
  • Hit the Books at the 2018 PDA Annual Meeting

    by: Rebecca Stauffer, PDA | Jan 29, 2018

    4 Academic Speakers to Address Innovation-Related Topics at Annual Meeting in March

    This year’s Annual Meeting will feature the following speakers representing academic institutions:

    • Steven Spear, PhD, Senior Lecturer, System Dynamics, Massachusetts Institute of Technology will speak on company dynamics in the second plenary, Monday, March 19, 4 p.m.
    • Paul Stey, PhD, Biomedical Data Scientist, will copresent on “New Approaches to Harnessing Data at a Portfolio Level” in “B3: Trends in Digital Information and Automated Technology,” Tuesday, March 20, 4 p.m.
    • Suzanne Farid, PhD, Codirector, Future Targeted Healthcare Manufacturing Hub, University College London, will present “Streamlining Biopharmaceutical Decision-Making,” in “A3: Agile Bioprocessing,” Tuesday, March 20, 4 p.m.
    • Matthias Gromeier, MD, Professor, Department of Neurosurgery, Duke University Medical School, will close out the meeting with his talk, “Polio Virus Vaccine Trial,” Wednesday, March 21, 2:15 p.m.

    More information about these and other speakers can be found at the Annual Meeting website.

  • You Spoke, PDA Listened

    by: Rebecca Stauffer, PDA | Jan 02, 2018

    2018 Annual Meeting to Feature New Format Based on Attendee Feedback from Past Meetings

    In response to feedback from attendees at previous Annual Meetings, we are trying a new format for the 2018 PDA Annual Meeting. This event will deliver the same high-quality content you have come to expect, but in a new lineup designed to better meet your needs.

    Here are the changes.

    • The meeting will now begin with the Opening Plenary at 1 p.m. on Monday, March 19
    • A Grand Opening Celebration will kick off in the Exhibit Hall at 5 p.m. on Monday, March 19—this is your first opportunity to meet with exhibitors and learn about the latest products and services
    • Interest group sessions will be held at the same time as breakout sessions, giving attendees more sessions from which to choose during the day and allowing for more free time in the evening
    • The Closing Reception will be the final event of the meeting and takes place after the close of the meeting on Wednesday, March 21, at 7 p.m.—be sure to stay and celebrate with us!

    Learn more about the 2018 PDA Annual Meeting.

  • 2018 Board of Directors

    by: Rebecca Stauffer, PDA | Jan 02, 2018

    PDA is pleased to announce the results of the 2018 Board of Directors and Officers election.

    Executive Committee

    The following candidates have been elected to serve as officers on the PDA Board of Directors:

    • Chair: Rebecca Devine, PhD, Biopharmaceutical Consultant
    • Chair-Elect: Jette Christensen, Scientific Director, Compliance, Novo Nordisk A/S
    • Treasurer: Michael Sadowski, Director, Research, Baxter
    • Secretary: Steven Lynn, Global Head, Group/Corporate Compliance and Audit, Novartis
    • Immediate Past Chair: Martin VanTrieste

    PDA also thanks Hal Baseman, COO, ValSource, who ends his term as Immediate Past-Chair.

    Directors

    PDA congratulates the following new and returning directors to the Board:

    • Masahiro Akimoto, Senior Manager, Research and Development and Quality Assurance Division, Otsuka
    • Kerry Ingalls, Vice President, Site Operations Amgen
    • Mary Oates, Vice President of Innovative Operations and Network Excellence, Pfizer
    • Emma Ramnarine, Senior Director Global Biologics, Genentech/Roche

    PDA also thanks outgoing directors Ursula Busse, PhD, Head Quality Intelligence and External Relations, Novartis, and Deborah Autor, Senior Vice President, Strategic Global Quality and Regulatory Policy, Mylan for their service on the Board.

  • PDA in the News

    by: Rebecca Stauffer, PDA | Nov 06, 2017

    Below is a sampling of articles that have mentioned PDA in the past few months.

    BioProcess International

    September 19, 2017

    “The Unican Concept: Engineering Dual Capability into Single-Use Vessels”Terry Hudson, Ekta Mahajan, Kelsey Dent and Edward Chan

    European Pharmaceutical Review

    August 31, 2017

    “A comprehensive review of the newly revised European Pharmacopoeia chapter 5.1.6”Michael J. Miller

    FDANews

    September 12, 2017

    “PDA Conference: Baxter Cuts 483 Rate With Quality Matrix”

    Healthcare Packaging

    September 11, 2017

    “Live from PDA/FDA: 5 Key Landscape Takeaways”Keren Sookne

    “Live from PDA/FDA: Culture of Quality”Liz Tierney

    September 13, 2017

    “Live from PDA/FDA: 3D Printing Applications”Keren Sookne

    September 14, 2017

    “PDA/FDA: Trends in Compliance and Enforcement"Keren Sookne

    Outsourcing-Pharma

    September 12, 2017

    “Cost of bad quality is much higher than cost of producing good quality, says PDA task force”Melissa Fassbender

    Pink Sheet

    October 5, 2017

    “EU Defends Plans To Keep ‘PUPSIT’ Testing In Revised EU GMP Annex 1”—Joanne Eglovitch

  • MHRA Inspector Covers Reasons for Annex 1 Update

    by: Rebecca Stauffer, PDA | Nov 06, 2017

    The Annex 1 revision process continues and the document is expected to be out soon. Although, according to Andrew Hopkins, Expert GMDP Inspector, UK MHRA, in his talk at the opening session of the 2017 PDA Annex 1 Workshop on Oct. 2 in Washington, D.C., he did not have a time frame for when the document would be available.

    Hopkins’ presentation provided extensive coverage of the reasons behind the revision. In his words, EMA recognized the document needed “tidying up.” The revision is expected to include Quality Risk Management (QRM) principles and address the need for manufacturers to keep up with new technologies.

    Additionally, the revised Annex 1 will keep the requirement that manufacturers conduct pre-use, post-sterilization integrity testing, commonly referred to as “PUPSIT.”

    Gabriele Gori, VP, Head of Quality Audit and Risk Management, GSK Vaccines, and Hal Baseman, Chief Operating Officer, Val- Source, currently head the PDA task force looking into the Annex 1 revision and working closely with European regulators. Members of this task force published the two-part Points to Consider for Aseptic Processing document in 2015 and 2016 in advance of the Annex 1 revision. Both Part 1 and Part 2 can be purchased from the PDA Bookstore.

  • Joint Statement from PDA and ISPE

    by: John Bournas, President and CEO, ISPE, and Richard Johnson, President and CEO, PDA | Nov 06, 2017

    October 11, 2017

    The pharmaceutical and biopharmaceutical community faces many challenges in our changing global environment. New technologies are required for manufacturing and control of a more diverse product portfolio; new techniques are needed for managing a global supply chain; and regular information is needed about the changing regulatory landscape.

    Fortunately, there are nonprofit organizations that work through their members to educate our industry, and also work together to define and disseminate consensus guidance and best practices. Nonprofit organizations fund these activities through membership dues, publication sales, and, in large part, through registration fees from education conferences and training courses. We pride ourselves on providing neutral, high-quality and reliable information to our members and attendees.

    Today, we see an increasing number of for-profit conference organizers who duplicate the content developed by nonprofit organizations, employ aggressive marketing techniques and charge high prices for that content. This siphons much needed support from nonprofit organizations such as ours.

    As leaders of two global member-driven organizations, ISPE and PDA, with nearly 30,000 members between us, we value the support that the community gives us. We are committed to fulfilling our missions, to guide our members and stakeholders toward using the best science and engineering to continue to provide high-quality, safe and effective medicines to serve patients.

    Furthermore, we are committed to continuing our collaborations that provide unbiased platforms for dialogue, such as in cross-industry initiatives and interassociation groups, among others, that benefit the global pharmaceutical and biopharmaceutical community.

  • FDA Delays Quality Metrics Portal

    by: Rebecca Stauffer, PDA | Oct 03, 2017

    The U.S. FDA continues to work on its quality metrics portal, though it will not be completed by the anticipated January date. Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA, made the announcement on Sept. 12 at the 2017 PDA/FDA Joint Regulatory Conference during the “Quality Metrics” session, moderated by Amgen’s Steven Mendivil, Senior Advisor, International Quality External Affairs.

    Bizjak went on to explain that the Agency is seeking volunteers to test the portal prior to launch. Inquiries can be made to OPQ-OS-QualityMetrics@fda.hhs.gov.

    The session also featured Valerie Whelan, Vice President, Corporate Quality, Amgen, who discussed Amgen’s metrics journey. Following the presentation was a panel discussion featuring Bizjak, Alex Viehmann (CDER, FDA), Barbara Allen, PhD (Eli Lilly), Deborah Autor (Mylan), Harry Jeffreys (Catalent Pharma Solutions) and Susan Schniepp (Regulatory Compliance Associates).

  • PDA Publishes PtC on Aging Facilities

    by: Walter Morris, PDA | Oct 03, 2017

    This summer, PDA published its Points to Consider for Aging Facilities document as part of an ongoing focus on manufacturing improvements. In some cases, noncompliant, aging facilities are a reason companies cease manufacturing, which may exacerbate drug shortages.

    Points to Consider for Aging Facilities reflects the general thoughts of the pharmaceutical manufacturing industry on how to identify and modernize aging facilities. It covers eight critical areas to help companies avoid the traps encountered by other companies: Recognizing an Aging Facility, Impediments to Modernization, Business Case for Modernization, Impact of Changing Standards, Slowing the Aging Process and Regulations.

    A team of industry experts developed this document based on responses to a PDA workshop held in March 2015 and a survey of PDA members conducted later that year. This team consisted of:

    • Ghada Haddad, Merck & Co./Merck, Sharp & Dohme, Co-Chair
    • Maik Jornitz, G-CON Manufacturing, Inc., Co-Chair
    • Glenn Wright, Eli Lilly and Company, Inc., Co-Chair
    • James Butler, Cimetrics
    • Jette Christensen, PhD, Novo Nordisk A/S
    • Phil DeSantis, DeSantis Consulting Associates
    • Robert Dream, PhD, HDR Company, LLC
    • John Lewis, DPS Consulting
    • Anette Marcussen, Novo Nordisk A/S
    • Morten Munk, NNE
    • Shelley Preslar, Azzur Group, LLC
    • Susan Schniepp, Regulatory Compliance Associates Inc.
    • Chris Smalley, PhD, ValSource
    • Matthew Taylor, Eli Lilly and Company
    • George Wiker, AES Clean Technology

    The document can be purchased at the PDA Bookstore.

  • Make Your Voice Heard: Vote for the 2018 BoD

    by: Rebecca Stauffer, PDA | Aug 29, 2017

    Each year, PDA members have an opportunity to help set the strategic direction of the Association by voting for Board of Directors candidates. This year, there are three open Officer seats (Chair-Elect, Treasurer and Secretary) and four open Director positions. Due to the change in PDA’s bylaws, three of these Directors will be directly elected by members with the fourth appointed by the Board.

    Elections are open until Nov. 15; members in good standing as of Aug. 24, 2017 can vote online or at conferences held before Nov. 15 in the United States and Europe.

    Officer Candidates

    • Jette Christensen (Chair-Elect>
    • Michael Sadowski (Treasurer)
    • Steven Lynn (Secretary)

    Director Candidates

    • Masahiro Akimoto
    • Aaron R. Goerke, PhD
    • Kerry Ingalls
    • Ivy Louis
    • Mary Oates, PhD
    • Emma Ramnarine
  • What is the Current State of Compounding?

    by: Rebecca Stauffer, PDA | Aug 29, 2017

    FDA Representatives to Discuss Impact of DQSA in Special Plenary at PDA Micro Conference

    This fall marks the fifth anniversary of the New England Compounding Center meningitis outbreak. In recognition of this tragedy and the importance of ensuring microbial control, three U.S. FDA representatives have been confirmed to speak in a special plenary session at this year’s 12th Annual PDA Global Conference on Pharmaceutical Microbiology. Moderated by CDER’s John W. Metcalfe, PhD, Plenary 4, “FDA Update on Human Drug Compounding: Regulatory Policy and Drug Quality” (Tuesday, Oct. 17, 4:15 p.m.), will feature the following FDA staff:

    • Julie Dohm, PhD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER
    • Sara Rothman, Senior Policy Advisor, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, CDER
    • Ian F. Deveau, PhD, Chief, Global Compliance Branch 1, Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance, CDER

    All three will discuss the 2013 Drug Quality and Security Act (DQSA) and its impact on FDA’s oversight of compounding facilities. To learn more, visit the website for the conference.