Press Releases (Card Grid)

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

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

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:

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.

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:

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.

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:

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.

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.

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.

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.

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.

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.

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.

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.

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.