Press Releases (List)
-
PDA Announces Availability of ANSI/PDA Standard 001-2020 on Purchasing Controls
Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of ANSI/PDA Standard 001-2020, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices, and Combination Products Industries, which was approved by the ANSI Board of Standards Review on March 13, 2020.
ANSI/PDA Standard 001-2020 is aimed at all personnel involved in the procurement, purchasing, or sourcing decisions within health care product manufacturing organizations. It makes clear that those who make the final decisions are responsible for the quality of the product, not just those in the manufacturing and quality units.
ANSI/PDA Standard 001-2020 is available at the PDA Bookstore and costs $325.00 ($180.00 for PDA members and government employees).
PDA is advancing five other standards
- BSR/PDA Standard 02-201x, Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine Manufacturing
- BSR/PDA Standard 03-201x, Standard Practice for Quality Risk Management of Aseptic Processes
- BSR/PDA Standard 04-201x, Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters
- BSR/PDA Standard 05-201x, Consensus Method Rating for 0.1 Mycoplasma Reduction Filters
- BSR/PDA Standard 06-201x, Quality Culture Assessment Tool
More information about PDA’s role in standards development: https://www.pda.org/scientific-and-regulatory-affairs/pda-ansi.
Find answers to standard development questions: https://www.pda.org/scientific-and-regulatory-affairs/pda-standards-frequently-asked-questions or reach out to standards@pda.org.
-
Parenteral Drug Association Announces its 2020 – 2026 Strategic Plan
Bethesda, Md. – The Parenteral Drug Association, Inc. (PDA) today announced the availability of its 2020 – 2026 Strategic Plan, which was developed to assist PDA in achieving its vision to be the premier global leader in advancing bio/pharmaceutical manufacturing, science, technology, and regulation to enable members to better serve patients. The plan was developed by PDA’s Strategic Planning Committee at the direction of the PDA Board of Directors.
“A new element of the 2020 – 2026 Strategic Plan compared with previous plans is it aligns across all PDA groups,” said Richard Johnson, PDA President/CEO. “All stakeholders, including the Board of Directors, advisory volunteers, and staff, will be expected to work to achieve the objectives in the plan.”
The drivers of the 2020 – 2026 Strategic Plan are to:
- Differentiate PDA from other organization to show value to and attract new members
- Develop members and volunteer pipeline
- Promote thinking globally and acting regionally
- Sustain PDA’s growth
For more details, including a video explaining the 2020 – 2026 Strategic Plan, got to: https://www.pda.org/about-pda/strategic-plan.
-
Parenteral Drug Association Announces Measures to Support Pharma/Biopharma Industries during Covid-19 Pandemic
Bethesda, Md. – The Parenteral Drug Association (PDA) announced that it is suspending membership expirations retroactively to March 1 and continuing until the end of June. All members will continue to enjoy the benefits of membership, even if you are unable to pay due to the impact of the corona virus pandemic.
“The PDA team wants everyone in our community to stay safe during this difficult time,” said PDA President/CEO Richard Johnson. “PDA remains dedicated to providing our members with the useful tools and resources you need, particularly when as they face unexpected challenges.”
While PDA puts in place alternative solutions for training and conferences, here is a partial list of the benefits you can take advantage of immediately as you continue to work and advance your career:
- Access to the full contents of all active Technical Reports on the Technical Report Portal
- Review the PDA Glossary of Pharmaceutical and Biotechnology Terminology
- Read the PDA Letter with its just-refreshed website. Share articles with your colleagues, as all new content will be open access during the COVID-19 crisis.
- Find peer-reviewed, industry-critical research at the PDA Journal of Pharmaceutical Science & Technology The Mar/Apr issue will be open access, so share with colleagues!
- Connect with the PDA Community across social media platforms including PDA Connect, PDA’s LinkedIn Group, on Twitter, including the US and Europe, and on PDA’s YouTube channel.
- And don’t forget that many local PDA Chapters are also active on social media; search for them on the same platforms where you find PDA.
- Catch up on your technical reading at the PDA Bookstore.
- Continue to enjoy member discounts on PDA Conference and Education registration, with new virtual options being added now.
-
PDA Names Former Eli Lilly Exec. Glenn E. Wright Vice President of Scientific and Regulatory Affairs Dr. Tina Morris is leaving PDA to become Executive Director at AAPS
Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the appointment of former Eli Lilly and Co. - Executive Glenn E. Wright as Vice President of Scientific and Regulatory Affairs, effective March 23. Mr. Wright most recently worked as Senior Director of Quality Operations at Exelead, a contract manufacturer. Mr. Wright also has worked for Amgen and Pfizer.
Mr. Wright’s career at Eli Lilly spanned more than 20 years, during which he served in a variety of functions that give him unique experience in both pharmaceutical science and regulatory affairs. These roles included auditor, QC manager, global regulatory affairs director, and senior director of manufacturing science and technology. Mr. Wright also spent nearly four years working at Eli Lilly Italia as the company’s quality head for Italy, where he set quality policy for device and sterile products manufacturing and distribution operations including the plant’s modernization and repurposing from dry products to sterile insulin filling.
“Mr. Wright’s long experience in sterile pharmaceutical manufacturing, control, and regulatory affairs will prove invaluable to PDA’s members,” said Richard Johnson, President and CEO, PDA. “I have known Glenn a long time both during my time as PDA President and as a volunteer before that, and I am confident Mr. Wright will be an excellent leader of PDA’s various regulatory and manufacturing science activities.”
Mr. Wright has been active with PDA since 1990. He served over 12 years on the PDA Board of Directors, over 10 years on the PDA Science Advisory Board, and most recently as co-chair of the PDA’s Aging Facilities Task Force and as co-chair of PDA’s Manufacturing Science and Operations Program. Mr. Wright also served as the chairman of the Product Quality Research Institute’s working groups on aseptic processing and working group on post approval changes for sterile products. Mr. Wright has received numerous industry awards and citations including the prestigious Frederick J. Carleton Award for his outstanding contributions to the PDA Board and the wider organization.
As PDA’s VP of Scientific and Regulatory Affairs, Mr. Wright will oversee PDA’s scientific and regulatory affairs activities, which include developing industry-leading technical reports, the standards program through the American National Standards Institute (ANSI), regulatory commenting, and collaborating with PDA’s technical/regulatory advisory boards.
Dr. Tina Morris joined PDA in 2018 and oversaw the development of PDA’s first six standards. She leaves PDA to become the American Association of Pharmaceutical Science’s executive director.
“PDA appreciates Dr. Morris’s leadership during a time when PDA was drafting its first standards,” said Johnson. “We know AAPS will be in capable hands, and we wish her good fortune in her new role.”
-
PDA Europe Parenteral Packaging to Address EU MDR 117 and Closed Systems
Berlin – Parenteral Drug Association Europe (PDA EU) is hosting its 10th Parenteral Packaging Conference in Basel, Switzerland, 25-26 February. The conference features presentations and discussions by industry leaders and technical experts from pharma and supplier companies. This year’s event includes expert discussions on the EU’s Medical Device Regulation 117 and on closed system transfer devices.
Stephanie Goebel, TÜV Süd Germany, will give the notified body perspective of EU MDR 117 and its impact on combination products during the opening session of the conference.
Closed systems transfer devices is the topic for breakout Track A. It features talks by a host of experts. Cathy Zhao, West, will discuss guidance on interconnectability of vial container closure systems and vial transfer devices. Zhao recently published an article in the PDA Letter titled, “Five Challenges of Closed System Transfer Devices,” which delves into the U.S. Pharmacopeia <800> Hazardous Drugs—Handling in Healthcare Settings, which went into effect on 1 Dec 2019.
Track B focuses on of the meeting focuses on packaging considerations for deep cold and cryogenic storage. This track includes three presentations on the challenges related particularly to cell and gene therapy products.
Other tracks will address container-closure integrity, glass, drug product-packaging interaction, sterilization and decontamination challenges, and the impact of new technologies and digitalization.
For the complete agenda, go to https://www.pda.org/global-event-calendar/event-detail/parenteral-packaging#overview
Press passes are available for conferences and workshops to bona fide members of the press: https://www.pda.org/about-pda/press-pass-request-form.
-
PDA and AAMI Announce Plans to Explore Collaborations
Bethesda, Md. – The Parenteral Drug Association (PDA) and the Association for the Advancement of Medical Instrumentation (AAMI) today announced their agreement to explore collaborations to further the missions of both organizations and enhance value to their members, stakeholders, and their respective communities at large. The two heads of each organization met at PDA’s headquarters on Jan. 29 to sign a collaboration agreement.
“This is a great opportunity to leverage the important work of both organizations,” said Richard Johnson, PDA President & CEO.
“We look forward to sharing with and learning from PDA’s staff and leaders to further both organization’s missions.” said Robert Jensen, AAMI President and CEO.
With similar missions and professional members in the pharmaceutical, biopharmaceutical and medical devices industries, AAMI and PDA see many areas in which the two groups can collaborate, including:
- Support joint projects
- Develop/evaluate common business systems
- Co-marketing publications, conferences and training courses
- Develop a joint meeting
- Offer members reduced price for joining other organization
-
PDA Announces 2020 United States Conference Schedule
Bethesda, Md. – The Parenteral Drug Association (PDA) today announced its schedule of U.S. conferences for the year. The busy schedule includes PDA’s signature events and new “hot topic” workshops.
The PDA Annual Meeting, Mar. 30–Apr. 1 in Raleigh, North Carolina, will focus on innovative medicines and manufacturing. Immediately following the event is the first “hot topic” workshop, “Pharmaceutical Manufacturing Data Science Workshop” (Apr. 2, same location).
PDA is the Premier Association Sponsor of Interphex, Apr. 28–30, at the Javits Center in New York City, and will offer lectures during the industry-leading trade show.
Three signature meetings are the highlight of PDA U.S. fall activities: PDA/FDA Joint Regulatory Conference (Washington, DC), PDA Universe of Pre-filled Syringes and Injection Devices (Las Vegas, NV), and 15th Annual PDA Global Conference on Pharmaceutical Microbiology (Washington, DC).
Here is the complete list of 2020 PDA’s USA conferences and workshops:
DATE EVENT LOCATION March 30-April 1 69th PDA Annual Meeting Raleigh, NC April 2 Pharmaceutical Manufacturing Data Science Workshop Raleigh, NC June 23 Cell Therapy Control Strategy Workshop Washington, DC June 24-25 Advanced Therapy Medicinal Products Conference Washington, DC September 14-16 PDA Annual Regulatory Conference Washington, DC September 16-17 Data Integrity Workshop Washington, DC September 23 Visual Inspection Interest Group Workshop Bethesda, MD September 24-25 Pharmacopeia Conference Rockville, MD October 5-6 16th PDA Universe of Pre-filled Syringes and Injection Devices Las Vegas, NV October 7-8 Combination Products Workshop Las Vegas, NV October 19-21 15th Annual PDA Global Conference on Pharmaceutical Microbiology Washington, DC October 21-22 Rapid Microbiological Methods Workshop Washington, DC PDA Europe announced its schedule in December. PDA Asia Pacific will announce their dates soon. For a complete list of PDA’s 2020 conferences, workshops, and educational courses, visit: https://www.pda.org/global-event-calendar
Press passes are available for conferences and workshops to bona fide members of the press: https://www.pda.org/about-pda/press-pass-request-form.
-
PDA Europe Releases 2020 Conference Schedule
Berlin – The Parenteral Drug Association (PDA) Europe today announced its 2020 events calendar, which includes nine conferences throughout the EU. These events are developed by all-volunteer subject-matter experts who work with PDA staff to help educate pharmaceutical professionals on important topics related to biopharmaceuticals, manufacturing science, and regulatory affairs.
Highlights include the 10th Parenteral Packaging Conference, which will be held in Basel, Switzerland, a hot spot of pharmaceutical manufacturing, 25-26 Feb.
The Visual Inspection Forum returns and will be held in Berlin, 21-22 Apr.
June will be a busy month for PDA Europe, as it hosts:
- Quality and Regulations Conference, Dublin, Ireland, 09-10 Jun
- Virus Forum, Brussels, Belgium, 22-23 Jun
- 11th Advanced Therapy Medicinal Products, Brussels, Belgium, 24-25 Jun. (to include simulcast with parallel event to be held in the United States).
PDA Europe is holding a new conference on Medical Devices and Connected Health, 08-09 Sept. in Madrid, and the second BioManufacturing Conference, 22-23 Sept, in Dublin.
For the first time, PDA Europe will host a conference dedicated to those in the community working in veterinary medicine. The Aseptic Animal Health Conference is scheduled for 20-21 Oct., in Den Haag, Netherlands.
In addition, PDA EU will hold 15 lecture courses, 5 stand-alone laboratory courses, and at least three workshops in 2020.
The full 2020 schedule of PDA Europe events with agendas and registration information can be found at www.pda.org under events and training. Sort for EU events. Press passes are available to members of the press.
-
PDA and IPEC Federation Publish Technical Report No. 54-6 Formalized Risk Assessment for Excipients
Bethesda, Md., / Brussels, Belgium – The Parenteral Drug Association (PDA) and the International Pharmaceutical Excipients Council Federation (IPEC) as an outcome of its collaboration established in March 2018, today announce the joint publication of a Technical Report for Formalized Risk Assessment for Excipients.
To comply with the European Commission Guidelines and PIC/S publication, excipients used in a drug product must be assessed for the risks that they pose to the drug product’s quality, safety, and purity. This requires drug manufacturers to ensure appropriate levels of GMP for excipients by using formalized risk assessments.
This joint PDA-IPEC Technical Report extends the PDA Technical Report No. 54 series on Quality Risk Management.
Highlights include:
- a model for quality risk assessment for excipients
- guidance on key GMP elements required for an excipient considering its source, supply chain and subsequent use
- a collection of actual examples from excipient users in the pharmaceutical industry
The Risk Assessment Technical Report is available:
- To members of IPEC sister associations via their respective members’ areas and to members of PDA’s via its website, www.pda.org.
- To purchase at https://www.pda.org/bookstore/product-detail/4405-tr-54-5-quality-risk-management
-
PDA Announces Election Results for 2020 Board of Directors; Jette Christensen Assumes Role as Chair, 2020-2021
Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the results of its Board of Directors Election for the term beginning January 1, 2020. Each year, PDA’s global membership votes to select new directors for the nonprofit Association’s all volunteer Board of Directors, and the Board appoints one Director. In odd years, the membership elects new volunteer officers, who serve two-year terms (except for the chair elect, who serves for six years as chair-elect, chair, and, finally, as immediate-past-chair).
This year, the following, well-qualified individuals were elected as officers:
- Chair-Elect .... Susan Schniepp, RCA
- Treasurer .... Glenn Wright, Exelead Biopharma
- Secretary .... Melissa Seymour, Biogen, Inc.
The three, long-time PDA volunteers join the Board’s Executive Committee led by Jette Christensen (Novo Nordisk) as the 2020-2021 Chair, and Rebecca Devine (consultant) as the 2020-2021 Immediate-Past-Chair.
The 2020 Directors are (* indicates elected or selected for the 2020 term):
- Masahiro Akimoto, Otsuka Pharmaceutical Factory, Inc.
- Barbara Allen, Eli Lilly and Company*
- Michael Blackton, Adaptimmune
- Bettine Boltres, West Pharmaceutical Services
- Tia Bush, Amgen*
- Ghada Haddad, Merck & Co.*
- Joyce Hansen, Johnson & Johnson*
- Stephan Krause, AstraZeneca Biologics
- Mary Oates, Pfizer
- Emma Ramnarine, Genentech/Roche
- Mathias Romacker, Pfizer (ret.)*
- Anil Sawant, Merck & Co.
"I want congratulate the new officers and directors and thank the many members who took the time to vote." said Richard Johnson, PDA President & CEO. "The diversity of our all-volunteer board of directors helps PDA continue to meet the needs of pharmaceutical and biopharmaceutical professions around the globe."
PDA thanks outgoing officers and directors: Martin Van Trieste, Mike Sadowski, Joyce Bloomfield, Veronique Davoust and Steven Lynn.
-
PDA GMP for APIs Education Webinar Now an "ICH Recognised Training Programme"
Bethesda, Md. – The Parenteral Drug Association (PDA) is proud to announce that its “ICH Q7 GMP for APIs” online training module is now endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as an “ICH Recognised Training Programme.”
The training module received the distinction after PDA demonstrated to ICH that it meets the twelve eligibility criteria for the program. Among these are its mission to serve as a neutral convening platform to engage expert stakeholders from industry, academia, advocacy groups, non-profits, and/or regulatory agencies on critical regulatory topics, and its promotion of regulatory convergence to accelerate innovation and improve healthcare globally.
The free “ICH Q7 GMP for APIs” training module introduces and improves understanding of the ICH quality guideline, Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The webinar is intended for pharmaceutical professionals working with APIs. More information on the webinar is available here: https://www.pda.org/global-event-calendar/ich-q7-gmp-for-apis.
-
U.S. FDA’s CDER Director Janet Woodcock and Johns Hopkins Researcher Thomas Stanton to Headline 2019 PDA Quality Week
Bethesda, Md., – The Parenteral Drug Association (PDA) today announced the participation of U.S. FDA Center for Drug Evaluation and Research Director (CDER), Janet Woodcock, MD, and Johns Hopkins University researcher and author, Thomas Stanton, MA/JD, as keynote speakers for the 2019 PDA Risk Management in the Regulatory Landscape Conference, at the Capital Hilton, Washington, DC, Dec. 9–10. The conference is the first of three during PDA’s first “Quality Week.”
Dr. Woodcock has served as the CDER Director since 2008 and has been instrumental in the formation of the CDER Office of Pharmaceutical Quality. She also led the Pharmaceutical Quality for the 21st Century Initiative in 2002 and has championed the role of risk management in pharmaceutical manufacturing and regulation. She will discuss how FDA currently views the application and future potential of risk-management approaches. She also will provide insight to quality risk management and if its potential has been fully realized. Finally, she will address the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality guidelines on risk management (ICH Q9) and quality systems (ICH Q10).
Thomas Stanton teaches at the Johns Hopkins University and is the past president of the Association for Federal Enterprise Risk Management. He has authored and co-authored numerous studies on risk management in the public sector, including Enterprise Risk Management (ERM): A Powerful Federal Management Tool. He will discuss the journey of introducing and establishing acceptance of ERM within the U.S. federal government.
On Dec. 11, Quality Week continues with 2019 PDA Building a Foundation for Quality Risk Management Integration Workshop, and on Dec. 12–13 with 2019 PDA Optimizing Quality Risk Management Conference.
More information on these events can be found at www.pda.org/2019QualityWeek. Members of the press are welcome to apply for a press pass. https://www.pda.org/about-pda/press-pass-request-form.
-
PDA Announces First Drug Delivery Innovation Award Winners at 2019 Universe of Pre-Filled Syringes and Injection Devices Conference
Bethesda, Md. – The Parenteral Drug Association (PDA) announced FujiFilm Kyowa Kirin Biologics, Co., Ltd. has won PDA’s new Drug Delivery Innovation Award and Congruence Medical Solutions and Santen Pharmaceuticals have won PDA’s Partnership in Drug Delivery Innovation Award. The Drug Delivery Awards were introduced in 2019 to recognize technical innovation advancing the field of bio/pharmaceutical manufacturing. The awards were announced at the 2019 Universe of Pre-Filled Syringes and Injection Devices Conference in Gothenburg, Sweden last week.
FujiFilm Kyowa Kirin Biologics Co., Ltd. was selected for the Drug Delivery Innovation Award for its Hulio™ non-citrate polymer syringe. Hulio™ is the biosimilar version of adalimumab. It is a new citrate-free formulation in an innovative container (SOF polymer syringe) with a thinner needle to reduce injection pain. The needle cover is not made of natural rubber latex to avoid latex allergy. This innovative product also has higher breakage resistance and is lighter than glass syringes.
Congruence Medical Solutions and Santen Pharmaceuticals received the Partnership in Drug Delivery Innovation Award for their work on a microliter dosing syringe (MDS). This MDS was conceived to provide an accurate, precise, microliter dose by incorporating a standard pre-fillable syringe. The innovation of this product is extending the range of currently available standard pre-fillable syringes to delivery of microliter doses. Applications can include delivery of proteins, antibodies, viruses, cells, gene, immunotherapeutics in ophthalmology, oncology, neurology, dermatology, and organ delivery, among others.
PDA will present these awards annually at the Universe of Pre-Filled Syringes and Injection Devices Conference. The 2020 event will be held Oct. 5-6 in Las Vegas. To learn more, visit pda.org/2020UPS.
-
ISPE and PDA Publish Guide to Improving Quality Culture in Pharmaceutical Industry
Bethesda, Md. – The Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE) today announce the joint publication of a guide for Root Cause Analysis (RCA) to help the pharmaceutical industry improve quality culture by providing recommendations for tools, techniques, and processes.
The organizations also announced today that they have signed a Memorandum of Understanding (MOU) confirming their plans to continue to advance practical approaches for quality culture. The first product of this collaboration is the RCA guide, which will assist the pharmaceutical industry in evolving and identifying best practices, tools and appropriate references for root cause analysis. The MOU leaves open the possibility that the organizations could directly collaborate on additional topics in the future.
The organizations selected RCA as the first topic in this undertaking as root cause analysis forms a significant part of any organization’s continuous improvement program. The lack of rigor applied to identifying the true root cause of failure events often leads to situations where the causal factors or effects of a given failure are identified and corrected, rather than the underlying cause. These symptoms of failure are often more visible and easily reported, while the actual root cause(s) of the problem may go unaddressed. This practical guide identifies a range of RCA tools along with recommendations for their application in the search for true root cause.
The RCA guide is available at ISPE’s website, www.ispe.org/ImproveCulture, and at PDA’s website, www.pda.org/ImproveCulture.
-
BSR/PDA Standard 01-201x on Purchasing Controls Available for Public Comment
Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of BSR/PDA Standard 01-201x, Enhancing Purchasing Controls to Support the Biopharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industry for public comment. To receive a copy of this draft standard, email PDA at standards@pda.org. The public comments period concludes Nov. 4. There is no charge for the draft standard.
Martin Van Trieste, Civica President & CEO, a former Amgen executive and PDA Immediate-Past-Chair, and Susan Schniepp, industry consultant and former PDA Director, co-chair the purchasing control committee.
“Historically in our industry the people who make the decisions on which suppliers to select in the negotiations of the contract are not in the quality unit or even manufacturing; they are in procurement or sourcing or a purchasing organization,” Van Trieste said. “We feel it is important not only does everyone have to be involved in the quality of the product, that the people who actually make those decisions are held accountable and this new ANSI standard will help do that.”
PDA is advancing five other standards
- BSR PDA Standard 02-201x, Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine Manufacturing
- BSR PDA Standard 03-201x, Standard Practice for Quality Risk Management of Aseptic Processes
- BSR PDA Standard 04-201x, Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters
- BSR PDA Standard 05-201x, Consensus Method Rating for 0.1 Mycoplasma Reduction Filters
- Quality Culture (pending ANSI approval)
More information about PDA’s role in standards development: https://www.pda.org/scientific-and-regulatory-affairs/pda-ansi. Find answers to standard development questions: https://www.pda.org/scientific-and-regulatory-affairs/pda-standards-frequently-asked-questions or reach out to standards@pda.org.
-
PDA Announces Keynote Speakers for 2019 PDA/FDA Joint Regulatory Conference
Bethesda, Md. – PDA is excited to announce the keynote speakers for the upcoming PDA/FDA Joint Regulatory Conference September 16-18 in Washington, D.C. These and other expert speakers will share their insight on how to improve the continued supply of high-quality drugs, biologics, and novel combination products to patients.
Marschall S. Runge, MD, PhD, Executive Vice President for Medical Affairs, University of Michigan will lead the “Academic and Clinical Perspective on Manufacturing Innovation and Achieving the 20/20 Vision” following the opening remarks about the keys to ensuring quality and promoting public health.
Then, Patrizia Cavazzoni, MD, Deputy Director for Operations, CDER, U.S. FDA, will share the “Regulatory Perspective.”
This year’s conference, themed “Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision,” will have 27presentations from the U.S. FDA and the other health authorities around the world. There will also be several panel discussions providing attendees an opportunity to ask the regulators questions, including the FDA Centers Updates session on Wednesday, September 18. On Tuesday, September 17, there is the “Lunch with Regulators” session, giving attendees a chance to interact with FDA investigators, reviewers, and compliance officers.
Go here to see the full conference agenda. https://www.pda.org/global-event-calendar/event-detail/2019-pda-fda-joint-regulatory-conference#agenda
Press passes are available here to bona fide members of the press. https://www.pda.org/about-pda/press-pass-request-form
-
PDA Announces Six Regulatory Authorities Speaking at Biomanufacturing in Munich
The Parenteral Drug Association (PDA) today announced representatives of seven health authorities have been invited to speak at the 2019 PDA Europe Biomanufacturing Conference, 3-4 September 2019 in Munich, Germany. The following health authorities have confirmed speakers:
- Danish Medicines Agency
- Dutch Medicines Evaluation Board
- European Medicines Agency
- European Directorate for the Quality of Medicines & Healthcare (EDQM)
- Swedish Medicines Agency
Mats Welin, Medical Products Agency, Sweden, and Dolores Hernan, European Medicines Agency, will provide an opening plenary talk on Accelerated Access and discuss the results of a 2018 EMA/FDA workshop on quality considerations for early access approaches. Those intrigued by Accelerated Access can learn more in the follow-up session, moderated by Martjin van der Plas, Dutch Medicine Evaluation Board. Welin and Hernan will participate in a panel discussion ending that session.
After a the first-day luncheon, Nanna Kruse, Danish Medicines Agency, will peel away some of the mystery surrounding the forthcoming International Conference on Harmonization (ICH) Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. In a parallel track, the Austrian Agency for Health and Food Safety (speaker TBD) will intrigue the audience with a review of challenges regulators routinely face with the advent of new vaccines and innovative biologics.
Bright and early on 4 September, the EDQM’s Gwenael Cirefice and the Dutch Medicines Evaluation Board (speaker TBD) turn the attention to ICH and advances in test methodologies. In a parallel track, Martjin van de Plas returns to the podium to review regulatory ideas regarding quality by design and control strategies. Hernan takes the mic as the conference’s last speaker to discuss EMA’s2025 regulatory science strategy.
The meeting will close with a panel discussion including all the regulatory representatives participating.
Learn more about the topics that will be examined in-depth and/or to register. https://www.pda.org/global-event-calendar/event-detail/biomanufacturing-conference
Members of the press are welcome to apply for a press pass. https://www.pda.org/about-pda/press-pass-request-form
-
PDA Launches Third Industry Standard: Standard Practice for Quality Risk Management of Aseptic Processes
Bethesda, Md. – PDA today announces the official launch of its third standard project, “Standard Practice for Quality Risk Management of Aseptic Processes” which is being chaired by Hal Baseman, Chief Operating Officer of ValSource, Inc.
Throughout 2019, PDA has made significant progress advancing its first two standards, “Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries” and “Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine Manufacturing.” Both preliminary drafts will be made available to the public for review in the coming months.
The final steps are underway to put together a working group for a fourth standard, “Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters,” and a 60-day open call for volunteers has just begun for a fifth standard, “Consensus Method for Rating 0.1 Mycoplasma Reduction Filters,” following an ANSI review.
In 2017, PDA earned approval from the Executive Standards Council (ExSC) of the American National Standards Institute (ANSI) as an Accredited Standard Developer (ASD) because its portfolio of technical reports, which has grown to nearly 80 active documents, included a number of topics that were excellent candidates to become American National Standards.
More information about PDA’s role in standards development can be found here https://www.pda.org/scientific-and-regulatory-affairs/pda-ansi.
Find answers to standard development questions https://www.pda.org/scientific-and-regulatory-affairs/pda-standards-frequently-asked-questions or reach out to standards@pda.org.
-
PDA Explores the Transformation of Healthcare at 4th Annual European Meeting
Bethesda, Md. – The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in Amsterdam, The Netherlands, the new location of the European Medicines Agency, where industry and regulatory agencies will present their perspectives on the transformation unfolding in the pharmaceutical sector regarding the digitalization and automation of manufacturing processes.
From the Max Planck Institute for Human Development, Felix G. Rebitschek will deliver the keynote speech, “Decision-Making Under Uncertainty.” Following him, the opening plenary “Regulatory Updates - Current Situation” will discuss understanding regulatory frameworks in an atmosphere of rapid change and provide the opportunity to participate in conversation with regulators and industry representatives.
Regulatory agencies sharing industry updates include the European Medicines Agency, U.S. FDA, WHO, MHRA and HPRA, PIC/S.
A series of parallel tracks will offer the chance to learn about topics ranging from virtual reality, data quality management, manufacturing technologies and much more.
Registration (https://store.pda.org/Meetings/Login.aspx?ID=4520) can be completed until June 24.
Members of the press are welcome to apply for a press pass. https://www.pda.org/about-pda/press-pass-request-form
-
PDA Announces All-Star Speaker Lineup for Advanced Therapy Medicinal Products Conference
Bethesda, Md. – The Parenteral Drug Association (PDA) is pleased to announce the speaker lineup for the 2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference, in Vilnius, Lithuania, June 4-5. Expert speakers representing industry, government and academia will cover the full breadth of scientific and regulatory considerations for successfully launching and manufacturing cell and gene therapies.
Lithuanian University of Health Science professor Romaldas Maciulaitis will get the meeting off to a quick start with his presentation, “Development and the Use of ATMPs in EU/Lithuania.”
Following him in the opening plenary session is Alistair Gibb from the UK Medicines and Healthcare Products Regulatory Agency, presenting “ATMPs System-wide Challenges from Innovation to Uptake – Pragmatic Supportive Regulation and Standards.”
The Paul-Ehrlich Institute’s Isabelle Bekeredjian-Ding takes the podium after her British counterpart with, “From Individualized to Standardized Microbiological Quality Control in ATMP Manufacturing.”
The PDA EU ATMP Conference comes just a month after PDA’s successful Cell and Gene Therapy Conference in Long Beach, Calif., May 6 – 7. That conference drew 200 participants. Earlier this year, PDA published Technical Report No. 81: Cell-Based Therapy Control Strategy.
Go here to see the full speaker lineup. https://www.pda.org/global-event-calendar/speaker-bios/europe/2019-atmps-conference
Press passes are available here to bona fide members of the press. https://www.pda.org/about-pda/press-pass-request-form