Press Releases (Featured)
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Four PDA Leaders Recognized on "the Medicine Maker" 2019 Power List
Bethesda, Md. – The Parenteral Drug Association (PDA) is once again well-represented on “the Medicine Maker” Power List—a list that celebrates pharmaceutical professionals for efforts to improve the industry in various ways. PDA President & CEO Richard Johnson, past-chairs Hal Baseman, Maik Jornitz and James Agalloco are recognized on the “Industry Influencer” list and past-chair Martin Van Trieste is on the “Champions of Change” list.
The 2019 Power List is put together by a panel of industry experts based on nominations solicited by “the Medicine Maker” from its readers. Only 100 industry professionals make the final list, divided into four categories of 25 each: Industry Influencers, Master of the Bench, Business Captains, and Champions of Change.
The list is available to registered readers at: https://themedicinemaker.com/power-list/2019
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PDA Europe’s Second Annual Pharmacopoeias Conference Furthers Engaging Dialogue
Bethesda, Md., – The Parenteral Drug Association (PDA) is proud to present the second annual Pharmacopoeia Conference, at the Crown Plaza Geneva, Switzerland, May 16-17. This year’s event features lectures from representatives of the pharmacopoeias of:
- Brazil
- Europe
- India
- Japan
- United States
Representatives from the World Health Organization and the UK’s Medicines & Healthcare Products Agency also will speak. Once again, the European Directorate for Quality of Medicines & Healthcare (EDQM) is chairing the conference.
Sessions will cover how pharmacopoeias function within their national regulatory frameworks, reference standards, manufacturing changes, and the convergence of standards. The conference will provide ample time for discussion, including a session for roundtable discussions of several important topics.“Following the success of the inaugural Pharmacopoeia Conference in 2018, PDA is pleased to present this event,” said Richard Johnson, President and CEO, PDA. “PDA appreciates the work of the EDQM in supporting this meeting and providing leadership the planning committee.”
Representatives from pharmaceutical companies also are participating as podium presenters, including from: Johnson & Johnson, GSK, Pfizer, Novartis, Biogen, Novo Nordisk, Ely Lilly and Company, and Hoffmann-La Roche.
Members of the press are welcome to apply for a press pass.
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PDA Confirms Five Regulatory Speakers at 2019 Biosimilars and Vaccines Conference
Bethesda, Md. – The Parenteral Drug Association (PDA) today confirmed five speakers representing global pharmaceutical regulatory agencies at the 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges, at the Hilton Long Beach, Long Beach, Calif., May 9 – 10, 2019. The confirmed regulatory speakers are:
- Anissa M. Cheung, MSc, Senior Regulatory Coordinator, CBER, U.S. FDA
- Maria T. Gutierrez Lugo, Supervisory Chemist, CDER, U.S. FDA
- Patrick J. Lynch, PhD, Lead Biologist, CDER U.S. FDA
- Klara C. Tiitso, Scientific Administrator, European Medicines Agency
- Maria Fernanda R S Thees, Manager of the Office of Biological Products, Agência Nacional de Vigilância Sanitária – ANVISA
This unique conference is really two events in one as it will explore the parallels between the manufacture, supply, and quality considerations of biosimilars and vaccines during the plenary sessions and focus on the distinctiveness of each in two concurrent tracks.
The Biosimilars Track will explore management of lifecycle similarities, regulatory and industry perspectives, and maximizing global development. The Vaccines Track will explore lifecycle management, new technologies, new platforms, and challenges.
The 2019 Biosimilars and Vaccines Conference is the third event offered during PDA’s Biopharmaceuticals Week, which begins May 6 with the two-day 2019 PDA Cell and Gene Therapy Conference. This event includes a regulatory talk by Steven Oh, PhD, Deputy Director, Division of Cellular and Gene Therapies, CBER, FDA.
https://www.pda.org/global-event-calendar/event-detail/2019-pda-cell-and-gene-therapy-conference
On May 8, the 2019 PDA Virus Safety Forum takes place with Arifa Khan, Sr. Investigator, Supervisory Microbiologist, CBER, FDA among the speakers.
https://www.pda.org/global-event-calendar/event-detail/2019-pda-virus-safety-forum
Press passes are available at https://www.pda.org/about-pda/press-pass-request-form.
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CNPPA To Provide China Regulatory Update at the 2019 PDA Parenteral Packaging Conference
Bethesda, Md. – The Parenteral Drug Association (PDA) today announced that Yonghua Gao, Deputy Secretary General at the China National Pharmaceutical Packaging Association will present a regulatory update of China’s packaging laws at the 2019 PDA Europe Parenteral Packaging Conference, March 19 – 20, at the Hilton Molino Stucky Venice, Italy.
The week’s program for the 2019 PDA Europe Parenteral Packaging conference is intended to initiate and support discussion and professional exchange through a diversity of scientific presentations, workshops, training courses, joint dinners and networking events.
Speaking on Wed. March 20, Gao will be joined in Session 4: “Regulatory Updates” by Bettine Boltres, West, and Horst Koller, HK Packaging, who will respectively speak on USP revisions to its glass and rubber standards and ISO 11040 on prefilled syringes.
Keynote speaker, Karthik Vaideeswaran, Sr. R&D Director, will present “The Evolution of Parenteral Drug Substance and Drug Product Primary Containers” on Tuesday, March 19.
Attendees will also hear a mix of experts from packaging suppliers and pharma/biopharma developers, including from LIGHTHOUSE, Gerresheimer, Roche, Corning, Genentech, Bristol-Myers Squibb, Novo Nordisk, SCHOTT, Novartis, and more. Academic researchers from Osaka University, University of Padova, and the Technical University of Denmark are also speaking.
Press passes for bona fide members of the press are available; please complete the online form here. https://www.pda.org/about-pda/press-pass-request-form.
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PDA Announces Opening of PDA Asia Pacific
Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the opening of PDA Asia Pacific, the U.S.-based Association’s second overseas office.
The move will better serve a growing membership throughout the Asia Pacific region and thriving chapters in Japan, Australia, Singapore, South Korea and Taiwan. With a permanent presence in Asia, PDA will increase the number of conferences and professional training offered to pharmaceutical professionals throughout the region. PDA expects to see membership there grow as well due to increased services.
“In accordance with PDA’s Strategic Plan, PDA is proud to announce the establishment of PDA Asia Pacific,” said Richard Johnson, PDA President & CEO. “Headquartered in Singapore, our team will help PDA expand our activities in this important region and support our members and chapters in the region. This will be a parallel organization to PDA Europe and PDA North America, and together with PDA Global Headquarters, will help us Connect People, Science and Regulation® across our community.”
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PDA to Unveil Technology Transfers Survey Results at 2019 Annual Meeting Technology Transfer Interest Group session to include discussion of survey
Bethesda, Md., – The Parenteral Drug Association (PDA) announced plans to release the results of its 2019 Technology Transfers Survey during the 2019 PDA Annual Meeting at the Marriott Marquis San Diego, Calif., March 11 – 13. The survey results will be discussed at the Technology Transfer Interest Group session on Tue., March 12, 10:45 – 12:15.
The session will also focus on the essentials of technology transfers, including a discussion of benchmarking, tools and tips, by Beth Haas, CAI, and John Wass, CAI.PDA is currently working on several initiatives relating to technology transfers, which are a necessary but complex part of modern drug and biologic manufacturing. Gathering data to better understand how companies implement technology transfers and the challenges that they encounter is the first step. PDA anticipates over 200 participants in the survey. Ultimately, the goal is to incorporate findings into a potential revision of PDA Technical Report No. 65: Technology Transfer and develop additional guidance on the topic—both using the survey results and the discussion generated at the PDA conference.
Each session at the 2019 PDA Annual Meeting: Solving Manufacturing and Supply Challenges for Current and Future Medicinal Products is designed to engage attendees in discussions on improving existing processes or entirely new technologies and therapies.
“The 2019 PDA Annual Meeting offers something for everyone in the PDA community, whether they are working on technology transfers, developing innovative manufacturing strategies, or maneuvering the various regulatory hurdles to innovation,” said Richard Johnson, PDA President & CEO. “I look forward to seeing the many advisory board, interest group, chapter and other volunteers who attend this meeting each year.”
Richard Johnson will be available to discuss important industry trends and PDA initiatives with members of the press on Mon., March 11, 3:10 – 3:30 (room location TBD). Press passes are available to bona fide members of the press.
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PDA Launches New Website
Following extensive surveying of members and customers, PDA redesigned and reorganized the entire website to make finding information easier and to improve the overall user experience. Visitors to the homepage will instantly see the following changes:
- More refined, cleaner design
- Condensed navigation options
- Improved search capability
- Enhanced mobile functionality
- New & Noteworthy section for pertinent member-oriented information
- Up-to-date industry news with feeds from the news uPDAte
The new site features “Topic Area” pages that consolidate all the relevant PDA activities, offerings and industry news onto pages dedicated to the following five areas of strategic interest to PDA members and customers:
- Aseptic Processing & Sterilization
- Biopharmaceuticals & Biotechnology
- Manufacturing Science
- Quality & Regulatory
- Supply Chain & Outsourcing
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PDA Announces Education Courses in India
Bethesda, Md., – The Parenteral Drug Association (PDA) today announced plans to offer its industry-leading courses in pharmaceutical science and aseptic processing in Bangalore, India to serve the industry at-large there. The first course, Aseptic Techniques, will be held in March 2019 and the final course, Microbial Data Deviations will be held in November.
PDA will work with EduOriens Skill Development LLP.
“PDA is pleased to bring its leading educational offerings to the pharmaceutical professionals in Bangalore, India,” said Richard Johnson, President & CEO, PDA. “We appreciate the efforts of EduOriens to help facilitate these courses.”
The full listing of courses is:- Aseptic Techniques - March
- Environmental Monitoring - April
- Aseptic Process Simulations - May
- Microbial Data Deviations - June
- Lyophilization - July
- Aseptic Techniques - August
- Environmental Monitoring - September
- Aseptic Process Simulations - October
- Microbial Data Deviations - November
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PDA Announces Diverse 2019 Board of Directors
Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the results of its Board of Directors Election for the term beginning January 1, 2019. In the fall of 2018, PDA’s 10,500 members had an opportunity to participate in the election of new directors.
The following candidates have been elected/appointed as Directors to the PDA Board of Directors for three-year terms starting Jan. 1, 2019:
- Michael Blackton, Adaptimmune
- Bettine Boltres, West Pharmaceutical Services*
- Stephan Krause, AstraZeneca Biologics
- Anil Sawant, Merck & Co.
- Melissa Seymour, Biogen
“I want congratulate the new Directors and thank the many members who took the time to vote.” said Richard Johnson, PDA President & CEO. “We had a high number of members vote in this year’s election, and I hope to see even more members participate in the future.
“PDA’s Board of Directors is one of the most diverse in the pharmaceutical industry, and it is the participation of our members in selecting the Directors that ensures this.”
PDA thanks outgoing Directors Susan Schniepp and Stephan Roenninger for their many years of service to PDA.
*Filling remainder of 2-year term of board member who resigned
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PDA Adopts Projects to Assist Pharma Manufacturers Data governance and predictive maintenance projects formed after consultation with PDA Manufacturing Science and Operations Program<sup>SM</sup>
Bethesda, Md. – The Parenteral Drug Association (PDA) is pleased to announce the formation of a PDA technical report team and a task force to advance projects to assist pharmaceutical manufacturers in key areas. Both projects were approved by the PDA Science Advisory Board and have spun out of PDA’s umbrella Manufacturing Science and Operations ProgramSM, which is an advisory body to PDA of leading experts in pharmaceutical manufacturing.
The technical report team has been sanctioned to draft industry guidance on the governance and control of big data implementation in manufacturing enterprise to ensure maximization of data insights.
The task force will examine predictive maintenance of equipment utilizing advanced statistical and mathematical methodology. This task force could produce a written case study in the form of a PDA technical report, journal article or other publication type.
“PDA is pleased to sponsor these important projects that will support pharmaceutical manufacturers throughout the industry,” said Richard Johnson, PDA President & CEO. “These are just the first of many projects PDA anticipates initiating in consultation with the MSOP advisory panel.”
Both projects are part of the overarching PDA/MSOP Manufacturing Intelligence Task Force, co-chaired by Michele D’Allessandro, Merck VP & CIO, and Aaron Goerke, Head of Manufacturing Science and Technology, Roche Singapore Technical Operations.
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PDA’s Pacific Northwest Chapter to hold Inaugural Event at Aptevo Therapeutics FDA compliance officers from Washington and Oregon to speak at kickoff reception
Bethesda, Md. – The Parenteral Drug Association (PDA) announced the formation of the Pacific Northwest Chapter, its newest chapter. The PDA Board of Directors voted to accept the chapter’s charter and its board of volunteer officers at its September meeting in Washington, DC. The chapter will provide a local forum through which technical professionals in Washington, Oregon, Idaho, Alaska, and British Columbia can support the advancement of pharmaceutical and biopharmaceutical science and technology.
The Pacific Northwest Chapter will hold a kickoff and welcome reception on November 8, 2018 from 6:00 – 8:30 pm at Aptevo Therapeutics in Seattle, Wash. This inaugural event will be attended by Richard Johnson, President and CEO of PDA, who will discuss the PDA's organizational structure, mission, and role in pharmaceutical manufacturing. The event will also feature a keynote presentation by local FDA compliance officers, Maria Kelly-Doggett and William Millar, who will be discussing lifecycle management of parenteral drugs. Officers Kelly-Doggett and Millar will also be fielding questions and providing information on local FDA resources.
The following experts will serve as the 1st volunteer officers for the PDA Pacific Northwest Chapter:
- President: Lisa Rutter, Partner Therapeutics
- President-Elect: Brian Hawkins, BioLife Solutions, Inc.
- Secretary: Irene Braginskaya, Nohla Therapeutics
- Treasurer: Anethra Wilson, Partner Therapeutics
- Members At Large: Alireza Abazari, BioLife Solutions; Julia Hart, Aptevo Therapeutics
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Speakers Wanted for the 2019 PDA Europe Parenteral Packaging Conference Pharmaceutical manufacturing professionals will share their skills and knowledge on a variety of packaging subjects
Bethesda, Md. – The Parenteral Drug Association (PDA) has released its Call for Abstracts for the 2019 PDA Europe Parenteral Packaging Conference: Interaction of Product, Package and Process, 19-20 March 2019 at the Hilton Molino Stucky in Venice, Italy.
Experts, thought leaders and practitioners are welcome to share case studies and successes, with a focus on new and innovative developments or works that significantly contributes to the body of knowledge relating to primary and secondary packaging of parenteral drugs.
This event attracts industry professionals from all over Europe who meet to advance their knowledge of and share their experiences with product and processes.
Presenting at the 2019 PDA Europe Parenteral Packaging Conference represents a chance for industry experts to speak about the industry’s top challenges and trends, including:
- Regulatory changes
- Container Closure Integrity (CCI)
- Quality of components and containers
- Processing/Product distribution and storage
- Formulation-Packaging considerations
- Aseptic processing
Benefits include networking, complimentary registration (for podium presentation), and demonstration of expertise to employer and peers.
The deadline to submit abstracts (https://www.pda.org/global-event-calendar/event-detail/parenteral-packaging#call-for-papers) is 19 November 2018.
Early-bird registration (https://www.pda.org/global-event-calendar/event-detail/parenteral-packaging#registration-fees) for the 2019 PDA Europe Parenteral Packaging conference expires 3 February 2019.
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U.S. FDA, Dutch MEB, and Health Canada Officials to Kick Off PDA’s Biosimilars Workshop Regulators joined on podium with experts from leading pharma companies
Bethesda, Md., August 17, 2018 – The Parenteral Drug Association (PDA) is pleased to announce the agenda for the 2018 PDA Biosimilars Workshop, “Getting it Right the First Time for Biosimilar Marketing Applications,” which will be held at the Renaissance Washington DC Downtown Hotel, Sept. 26 – 27.
The workshop features expert presentations from officials from the U.S. FDA, the Netherland’s Medicines Evaluation Board (MEB), and Health Canada during the opening session of the workshop, 2:00 pm – 3:15pm on Sept. 26. The session will explore the challenges encountered with the submission of marketing authorizations for biosimilar products. R. Martijn van der Plas, PhD, Senior Assessor Biologicals will present for MEB and Chantal Depatie, PhD, Biologist Evaluator, will represent Health Canada.
Interactive breakout sessions will follow, and the first day of the workshop will close with a panel discussion with the regulators. Day two of the workshop features additional talks from the regulators and presentations from experts representing companies like Pfizer, CELLTRION, and Novartis
Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, at FDA’s Center for Drug Evaluation and Research, will participate in the Day one panel discussion and provide the closing remarks.
The 2018 PDA Biosimilar Workshop immediately follows the PDA/FDA Joint Regulatory Conference, which takes place at the Renaissance Washington, DC Downtown Hotel Sept. 24 – 26. Press passes are available for both events.
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“What’s in Your Data? PDA Tackles Insights at the Shop Floor” Featured Talk at 2018 PDA Europe Annual Meeting
Bethesda, Md. – The Parenteral Drug Association’s (PDA) Manufacturing Science and Operations ProgramSM (MSOP) Manufacturing Intelligence Task Force will present an update on its activities on Tuesday June 26 at 15:20 CET during the PDA Europe 3rd Annual Meeting at the Berlin Marriott. Aaron Goerke, Roche, who is the volunteer co-chair of the committee and the chair of MSOP, will present.
PDA and MSOP formed the Manufacturing Intelligence Task Force in late 2017 to develop strategies to assist the industry with the use of Big Data to improve bio/pharmaceutical manufacturing and supply chain management. In less than 9 months the cross-industry Task Force facilitated an Ideation session, hosted a Manufacturing Intelligence Workshop in Orlando, Florida in March, and outlined a Strategic path to assist the industry during the fourth industrial revolution, Industry 4.0.
“The massive amounts of data generated as part of Industry 4.0 is often seen as disruptive in and of its self,” Goerke says. “But we believe the disruption is the way the data is processed, made available, and ultimately used to drive outcomes.”
Task force participants are discussing the data structure, data process and data science corresponding to insights gained to meet many of the challenges surrounding global manufacturing in a regulated bio/pharmaceutical industry.
Come hear about this journey and acquire an understanding of how the team is developing Digital Strategies to drive Manufacturing and Supply chain reliability at the PDA Europe 3rd Annual Meeting in Berlin!
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PDA-Funded Study on Post-Approval Changes Published by The Economist Intelligence Unit
Bethesda, Md.: PDA today announced the availability of "Medicine and vaccine shortages: What is the role of global regulatory complexity for post approval changes?", a report by The Economist Intelligence Unit. PDA commissioned the report with funds from the Parenteral Drug Association.
The report aims to explore whether the varying regulatory requirements for post approval changes to pharmaceutical products across the world are associated with medicine and vaccine shortages. The report confirms that drug product shortages are an ongoing global problem, and the causes of shortages are complex, multifaceted and not well understood. Finding a permanent solution for shortages is critical for achieving global health goals. While unable to correlate the global regulatory complexity for post approval changes to drug shortages, the report found it could be an aggravating factor that delays or hinders shortage mitigation actions. There is universal agreement that regulatory convergence and harmonization are beneficial to all stakeholders, and that trust and political will are required for harmonization and convergence initiatives to succeed.
"PDA is proud to have funded this important research," said PDA President/CEO Richard Johnson. "PDA thanks both the researchers from The Economist Intelligence Unit and PDA volunteers from the Post Approval Change: Innovation for Availability of Medicines Task Force for supporting this effort."
"Medicine and vaccine shortages: What is the role of global regulatory complexity for post approval changes?" is available to both PDA members and nonmembers at no cost at: http://graphics.eiu.com/upload/topic-pages/medicine-shortages/Medicine-and-vaccine-shortages-EIU.pdf
Medicine and vaccine shortages: What is the role of global regulatory complexity for post approval changes?
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PDA Advances Annex 1 Activities with Workshop, PUPSIT Consortium
Bethesda, Md., June 4,2018 – The Parenteral Drug Association (PDA) is advancing its activities involving the recent release of the draft revision to EU GMP Guideline Annex 1, the European guideline for sterile medicinal products with a recent in-depth workshop on the topic and the formation of a consortium to address pre-use and post-sterilization integrity testing for sterilizing grade filters (PUPSIT).
PDA’s Europe office hosted “Annex 1: Revision of the EU GMP Guideline” workshop at the Crowne Plaza Dublin-Blanchardstown, Dublin, Ireland, on May 17. The workshop planning committee, led by Gabriele Gori, GlaxoSmithKline, organized the meeting to facilitate open discussion among industry and regulatory representatives.
The latter included Greg McGurk, Senior Inspector, Health Products Regulatory Authority (HPRA), Ireland, and Dr. Beate Reutter, GMDP Inspector, German state of Schleswig-Holstein, who both shared their perspectives on the draft guidance. Over 150 registrants attended the workshop and participated in lively dialogue.
PDA also recently finalized agreement to participate in a consortium with the Biophorum Operations Group (BPOG) on the Annex 1 requirement for PUPSIT, which will bring together the leading biopharma manufacturers to explore the necessity of this stipulation. The consortium will include all major filter suppliers, most major aseptic manufacturers, and the regulatory authorities concerned about the possibility of filter/filter integrity test failures. The program will create three workgroups that will:
- Define an encompassing risk assessment scheme that will locate the conditions necessary to perform and best deploy PUPSIT
- Define known and unknown failure modes and conditions where pre-use failed filters can be masked
- Study protocols to test and examine failure modes to see if they too can be masked
- Conduct filter locking studies of pre-use flawed filters
- Create a harmonized FMEA to include graduated scaled of risk when using PUPSIT
- Create practice statements for the design and use of the system in different areas
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PDA Congratulates Current and Former Leaders for Recognition as Top “Industry Influencers” in 2018
Bethesda, Md., May 14, 2018 – The Parenteral Drug Association, Inc. (PDA) is pleased to announce that President & CEO Richard Johnson and past Chairs Martin Van Trieste, Maik Jornitz, Harold Baseman, and James Agalloco have been recognized by The Medicine Maker as among the top 25 “Industry Influencers” in 2018.
“The Medicine Maker 100 Power List 2018” is divided into four categories of 25 “outstanding professionals.” The PDA-related professionals appear in the “Industry Influencers” segment of the Power List, with Johnson and Van Trieste listed as the top one and two influencers, respectively. Agalloco ranked 11th, Baseman 12th and Jornitz 19th. Last year, Johnson, Van Trieste, Jornitz and Agalloco were also in the listing of the top 25 influencers. The complete list is available at The Medicine Maker.
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PDA, ISPE Sign MOU on Quality Metrics & Culture
Bethesda, Md., May 7, 2018 – The Parenteral Drug Association (PDA) and the International Society of Pharmaceutical Engineers (ISPE) announced today that they have signed a Memorandum of Understanding (MOU) to exchange information regarding their respective efforts on Quality Metrics and Quality Culture.
PDA pursued a Quality Culture Assessment to define quality culture attributes and has collected, analyzed and published data and worked to establish a correlation to operational excellence. ISPE collected, analyzed and published industry survey data that correlates pharmaceutical manufacturing metrics to quality outcomes.
Under the MOU, the two organizations agree to share relevant documents developed by their respective quality metrics/culture teams. The MOU leaves open the possibility that PDA and ISPE could directly collaborate on these topics in the future.
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PDA Inaugural Conference Draws Participation of Seven National Pharmacopoeias
Bethesda, Md., April 30, 2018 – The Parenteral Drug Association (PDA) is proud to present its inaugural Pharmacopoeia Conference held at the Renaissance Wien Hotel, May 29-30, Vienna, Austria, which features lectures from representatives of the pharmacopoeias for Europe, the United States, Russia, China, Japan, India, and Ghana. The European Directorate for Quality of Medicines & Healthcare (EDQM) is chairing the conference.
Representatives from these pharmacopoeias will share approaches to international convergence and the future direction of pharmacopoeias with respect to the overall framework of regulations and guidelines. The pharmaceutical industry will provide insights into their best-practices to effectively and efficiently implement international pharmacopoeial requirements.
“PDA’s inaugural Pharmacopoeia Conference is the first of its kind,” said Richard Johnson, President and CEO, PDA. “No other organization has been able to bring together so many different pharmacopoeias under one roof.”
The World Health Organization, the Eurasian Economic Union Pharmacopoeia Committee, the British Medicines and Healthcare Products Regulatory Agency, and the European Federation of Pharmaceutical Industries and Associations (Efpia) are also participating. Industry representatives from Amgen, Biogen, Ely Lilly and Company, Genentech, Merck Sharp & Dohme FCU, Novartis and Novo Nordisk will also speak.
A pharmaceutical product submitted and marketed in different countries or economic regions must comply with the respective pharmacopoeias legally binding in those countries and regions. Typically, however, international pharmacopoeias differ in the requirements for the same product. Compliance, therefore, becomes a major challenge for pharmaceutical companies.
Members of the press are welcome to apply for a press pass.
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PDA Names Tina Morris, PhD, Vice President of Scientific and Regulatory Affairs Dr. Morris succeeds Dr. Rich Levy, who is retiring after 13 years with PDA
Bethesda, Md., April 23, 2018 – The Parenteral Drug Association (PDA) is pleased to announce that Tina Morris, PhD, has been named Vice President of Scientific and Regulatory Affairs, effective June 4, 2018. Dr. Morris currently serves as Sr. VP of Compendial Sciences at the U.S. Pharmacopeia, with whom she has worked for 15 years.
In her new role, Dr. 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.
Dr. Morris began her career at USP as a senior scientific liaison in 2003, and saw her responsibilities grow each year before becoming Senior VP 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 BSc and MS in biology from the Carl von Ossietzky University in Oldenburg, Germany.
Richard Levy, PhD, PDA's outgoing Sr. VP of Scientific and Regulatory Affairs, announced his retirement earlier this year after 13 years in the role. Among his many accomplishments in the role, Dr. Levy oversaw a marked increase in the number of technical documents published annually, the conversion of the PDA Journal of Science and Technology from a print to an online-only publication, and the growth of the Scientific and Regulatory Affairs department staff to levels that can better support the efforts of member volunteers. Dr. Levy will take on the role of Editor of the PDA Journal of Pharmaceutical Science and Technology on May 21.
"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."