Press Releases (Card Grid)

Bethesda, Md., May 28, 2015 – The Parenteral Drug Association (PDA) proudly announces that it will be a supporting organization of the Johnson & Johnson Kilmer Conference on sterility assurance and sterilization in 2016.

Johnson & Johnson (J&J) is reviving the conference after a series of high-profile superbug infections in endoscopes. J&J ran 8 conferences on sterilization, validation and world health issues between 1976 and 2003 on advances in sterilization and other topics.

PDA joins the Association for the Advancement of Medical Instrumentation (AAMI) as a supporting organization of the May 2016 event.

PDA President and CEO Richard Johnson credits J&J for reviving this important event at a time when sterility assurance remains a critical issue. "PDA is pleased that J&J is resuming Kilmer Conference in 2016. PDA members across the globe are experts in the area of sterilization and sterility assurance for pharmaceutical products, and we are proud to be able to support this effort. Like J&J, PDA has spearheaded efforts to bring the latest in sterilization technology and science to the pharma industry, and the focus of many of our publications, conferences and training courses is in this area."

Bethesda, Md., May 6, 2015 – The Parenteral Drug Association (PDA) Board of Directors today announced that it has finalized agreement with Richard M. Johnson to continue as President and CEO through 2021.

"We are very pleased to have Richard Johnson continue as our President and CEO," said Hal Baseman, the Chair of the Board of Directors. "Under Richard’s leadership, PDA enjoyed significant success, performance and growth.  Richard has led a strong staff and dedicated volunteers, hosting PDA’s largest meetings, publishing a record number of technical reports, expanding membership and services globally, and facilitating increased participation of regulators. This continuity of leadership ensures that PDA will play an ever increasing role in providing unmatched services to its members and our industry for many years to come."

Richard joined PDA as President in 2009 following a 30-year career in the pharmaceutical industry, which included 20 years as an active PDA volunteer and member.

WHAT

A press conference to provide updates on PDA’s Manufacturing Science ProgramSM, Aseptic Processing Points to Consider and other activities in 2015.

WHO

Richard Johnson, PDA President/CEO
Hal Baseman, PDA Chairman, COO, ValSource LLC

WHERE

Red Rock Casino Resort and Spa
Room: Veranda C
Las Vegas, Nev.

WHEN

Monday March 16, 2015
10:15 am - 10:45am

Bethesda, Md., December 10, 2014 – The Parenteral Drug Association (PDA) announced today the results of its 2014 Board of Directors election. PDA members voted for four volunteer directors over a period of three months this past fall.

Re-joining the Board for a second three-year term is:

• Ursula Busse, PhD, Head GxP Regulations Coordination, Group Quality External Relations, Novartis, will "work to strengthen PDA's presence in Europe and other regions of the world."

Joining the Board for a three-year term are:

• Former FDA official Deborah Autor, Sr. VP, Strategic Global Quality and Regulatory Policy at Mylan, is excited to "help PDA continue to be a leading organization for manufacturing science, quality, and innovation, as well as an important bridge between industry and regulators worldwide."
• Masahiro Akimoto, General Manager, Compliance Division, Toray Industries, looks forward to continuing "continue to encourage the use and sharing of PDA knowledge among membership by coordinating or facilitating interactive communication."
• Emma Ramnarine, Global Head, Biologics QC Network, Roche Pharma, plans to help "drive PDA's strategy from the board level and further strengthen PDA's collaboration with FDA, EMA, PIC/S and other health authorities."

"We are pleased to welcome to our Board of Directors four outstanding contributors to our Association and our industry," said PDA President Richard Johnson. "These volunteers will join an active and dedicated Board of Directors that has helped grow PDA's service to members over the past several years through strong leadership and collaboration with the PDA professional staff."

Each year, PDA members vote to fill spots on the volunteer Board of Directors and every other year, they also vote for the Board's officers.
The terms of three Directors came to an end in 2014:  John Finkbohner, Junko Sasaki, and Chris Smalley.

"On behalf of PDA's 10,000 members, the Board of Directors, and the staff, I want to thank those Directors whose terms have concluded," Johnson said. "We look forward to their continued contribution to the community through their ongoing volunteerism in other PDA activities."

Washington, D.C. (December 4, 2014) – The Parenteral Drug Association (PDA) today closed its second annual Pharmaceutical Quality Metrics Conference with panels of distinguished representatives of pharmaceutical companies and officials from the U.S. FDA, the European Medicines Agency and the UK's regulatory body for medical products. Nearly all of the conferences 250 attendees remained engaged through the final panel discussions Thursday.

The PDA conference represented the first time the European Medicines Agency commented on FDA’s quality metrics program. The EMA representative noted that European inspectors collect quality metrics data during inspections, but not in advance and that comparing metrics across companies/product lines is difficult because of regional differences. However, the European officials applauded the FDA effort and indicated that they are closely watching the situation. They expressed hope that eventually a harmonized approach can be reached so companies are not overburdened with having to provide different sets of metrics to different agencies around the world.  The 2014 workshop also took on the difficult task of defining quality culture, and possible objective metrics of culture in a pharmaceutical manufacturing environment. The dialogue from the workshop, combined with the results of the survey, will factor into a future PDA paper that will help companies evaluate the strength of their quality cultures.

U.S. FDA officials set up the dialogue in the first few plenary sessions by presenting quality metrics that could help inform the Agency’s risk based inspection model.   

The subsequent dialogue sessions provided industry participants an opportunity to comment and offer feedback on aspects of quality culture metrics as well as the FDA proposal. 

PDA provided electronic voting devices in multiple breakout dialogue sessions, facilitated by both an industry and U.S. FDA representative, for the collection of audience feedback on a number of questions related to quality culture behaviors,  possible quality culture metrics, and the FDA proposals. 

Following what many attendees called this opportunity to “speak up” on quality metrics, FDA retook the podium on Wednesday in an ad hoc plenary session to re-explain its position on quality metrics. FDA stressed that pharmaceutical quality metrics gathered under the authority of the Food and Drug Administration Safety and Innovation Act will be used as intelligence by the Agency during a structured review process and not drive regulatory action. A key objective for the Agency gathering this additional data is to address drug shortages. Such metrics, which PDA and other industry groups have helped define over the last year, will help FDA allocate its limited inspection resources towards companies at the greatest risk of noncompliance.

FDA plans to compare metrics across products and manufacturing sites.

The conference closed with two different panel discussions. The first included quality professionals from several branded and generic drug companies. The last panel was composed of officials from various FDA divisions and representatives from European regulatory bodies.

Conference participants appreciated the open dialogue and left with the strong understanding that culture matters to product quality and that much more work remains to be done to determine the best ways to foster and support a strong quality culture across all sectors of the pharmaceutical  industry.

Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing now available

Bethesda, Md., October 16, 2014 – The Parenteral Drug Association (PDA)  announces the completion of guidance on the application of single-use, or disposable , systems in the manufacturing operations for pharmaceutical and biopharmaceutical products with the publication of Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing.

Single-use technology, often described as single-use systems (SUS) or single-use equipment, has the potential to transform pharmaceutical manufacturing by offering tremendous opportunities to reduce cost, improve flexibility or cycle time, and shorten the time needed to build a manufacturing process for new, life-saving drugs. This success, however, is very much dependent on how effectively the industry ap­proaches the development and implementation of single-use technology.
PDA Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing is intended to provide the reader with critical concepts or points to consider when implementing an SUS strategy in a pharmaceutical manufacturing process. These concepts are in­tended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products.

“PDA thanks the task force team of volunteers that produced Technical Report No. 66 for their hard work in ensuring that the document represents the most up-to-date best practices in the application of single-use systems,” said PDA President Richard Johnson. “The task force team of authors and contributors was diverse, representing large and small drug manufacturers, vendors to the industry and even the U.S. FDA.”

The team of authors was:

Contributors to the document were:

Bethesda, Md., September 19, 2014 – The Parenteral Drug Association (PDA) is moving forward with an initiative to harmonize global post-approval changes protocols.

The new initiative stems from the high level of interest in the topic expressed by industry participants and regulatory authority representatives at the PDA Drug Shortages workshop, held earlier this month in Washington, DC. Representatives of both the U.S. FDA and EMA were on hand for the workshop. Attendees indicated openness to engaging regulators and industry in further dialog on ways to expedite post-approval changes as a preventative measure for drug shortages, which in recent years has become a high priority for regulators.

“By establishing common global change protocols, we will be able to facilitate further harmonization across the various health authorities in terms of expediting changes to manufacturing processes, equipment and other processes for marketed products,” said PDA President Richard Johnson. “This would help mitigate potential drug shortages arising from typically extended change approval periods due to often varying approval requirements and processes between different Health Authorities.”

PDA is forming a Task Force to establish common global change protocols for typical types of manufacturing changes and providing a template for post approval change management plans will be one important tool. Companies could submit these prospectively to discuss planned changes across multiple Health Authorities. The goal is to help incentivize companies to implement new technologies and to continually improve product quality and process capabilities and to address the risk of drug shortages caused by aging manufacturing and analytical technologies.

The workshop was the most comprehensive industry and health authority event on drug shortages prevention. The well-attended meeting had presentations and active dialog between representatives of large and small pharma and the U.S. FDA and the EMA. Industry representatives shared their collective experiences, knowledge, and ideas on how to ensure uninterrupted supply of safe, efficacious medicines to patients. Full conference proceedings will be available soon.

PDA announced other aspects of its activities to help companies manage and prevent drug shortages at a press conference prior to last week’s workshop, including the development of a product-focused, risk-based framework described in a Technical Report due out later this year. 

Washington, DC, September 9, 2014 – The Parenteral Drug Association (PDA) today announced its plans to publish a Technical Report on the prevention and management of drug shortages. Short supplies and disrupted supply chains of critical, life-saving medicines are becoming an increasing problem for healthcare practitioners and patients in recent years. Regulators in the United States and Europe have been reaching out to industry to find ways to mitigate the kinds of shortages driven by manufacturing disruptions resulting from quality problems and regulatory enforcement activities.

PDA has assembled a team of volunteers representing large and small pharmaceutical and biopharmaceutical manufacturers to develop an industry guidance on this critical topic. The Technical Report, planned for publication in early 2015, will introduce two unique foundational concepts:

1. Risk-based triage on how to establish end-to-end controls for drug shortage risks based on criticality of the product and the overall product risk evaluation;
2. Holistic framework and template for establishing a drug shortage prevention and response plan.

“PDA is pleased to be working on this important initiative in support of regulatory initiatives in the U.S. and EU,” said PDA President Richard Johnson at a press conference held at the Renaissance Hotel in Washington, DC during the 2014 PDA/FDA Joint Regulatory Conference. “PDA’s activities in quality risk management started in 2009, and the Association has published four Technical Reports on the topic since then.”

This series of PDA Technical Reports started with Technical Report No. 54: Quality Risk Management, published in 2012; three annexes to that report have published subsequently. The new drug shortage document will continue that series.

PDA also announced at the press conference that a revised PDA Points to Consider on Pharmaceutical Quality Metrics is ready for publication in the PDA Journal of Pharmaceutical Science and Technology later this month. The revised paper includes definitions of various quality metrics and is intended to prompt discussion at the second PDA workshop on quality metrics scheduled for December this year.

Bethesda, Md., September 5, 2014 – The Parenteral Drug Association (PDA) today launched one of two surveys on Quality Culture Metrics as part of its continuing program to evaluate quality metrics that can inform the regulator’s risk-based inspection programs.

The first Quality Culture Metrics survey is open to all PDA members with a background or interest in pharmaceutical quality. PDA is sending a link to the survey to selected members based on this criteria. On September 6, a second Quality Culture Metrics Survey will be launched with controlled participation limited to three or four executives at selected companies. The surveys will be open for participation until October 2, 2014.

“PDA is excited to launch the Quality Culture Metrics surveys, the second leg of our ongoing pharmaceutical metrics program,” said PDA President Richard Johnson. “The volunteer PDA Quality Metrics Task Force put together a points to consider document on quality metrics in the first leg, and will initiate the third leg with a conference on pharmaceutical quality metrics later this year.”

PDA is conducting the 2014 PDA Quality Culture Metrics Survey to understand to what degree PDA members’ companies are measuring quality culture and to identify attributes of quality culture appropriate for use as metrics. Respondents are encouraged to base their answers on tools and approaches used at their local work site or facility. 

Results will be presented at the 2014 PDA Pharmaceutical Quality Metrics Conference on December 4, 2014 in Washington, DC.

Bethesda, Md., June 18, 2014  – The Parenteral Drug Association has confirmed the participation of 27 officials from the U.S. FDA, including CDER Director Janet Woodcock, MD, as speakers at the 2014 PDA/FDA Joint Regulatory Conference. Besides the Center for Drug Evaluation and Research (CDER), the FDA Centers for Biologics Evaluation and Research (CBER),  Devices and Radiological Health (CDRH), and Veterinary Medicine (CVM), along with the Office of Regulatory Affairs (ORA), will be represented on the podium during the conference.

“PDA membership works in a wide range of industries, so it is important they hear the viewpoints from officials in the various centers,” said PDA President Richard Johnson. “It is also critical that our members understand the latest Agency initiatives in order to be able to perform effectively for their companies, and have the opportunity to interact with key regulators to ask questions and understand the background and various perspectives.”

The following is a list of the confirmed FDA speakers, alphabetically listed with their center/office indicated: