Press Releases (Card Grid)
Four U.S. FDA Supply Chain Experts to Answer Industry Questions at PDA Conference
Bethesda, Md., April 21, 2014 – The Parenteral Drug Association (PDA) announced today that it has confirmed the participation of four experts from the U.S. FDA in the upcoming 2014 PDA/FDA Pharmaceutical Supply Chain Conference,June 3-4, 2014, at the JW Marriott in Washington, DC.
The four U.S. FDA experts represent the Center for Drug Evaluation and Research (CDER) Office of Compliance Office of Drug Security, Integrity and Recalls (ODSIR):
- Thomas Christl, Office Director
- Connie Jung, PhD, Associate Director, Policy & Communication
- Mark Paxton, Regulatory Counsel
- Steven Wolfgang, Acting Associate Director, Risk Science, Intelligence And Prioritization
“PDA is pleased to once again provide industry representatives an opportunity to interact with representatives of the U.S. FDA at one of our regulatory meetings,” said PDA President Richard Johnson. “This will be the fifth time PDA and the U.S. FDA have cosponsored a conference or workshop on the important issue of securing the supply of quality pharmaceutical ingredients and products.”
The U.S. FDA speakers will field questions during the final plenary session of June 3. Brian Johnson, Sr. Director, Supply Chain Security, Pfizer, Inc., and chair of industry consortium Rx-360, will moderate the session.
Building on earlier PDA/FDA-cosponsored conferences and workshops on pharmaceutical supply chains, the 2014 event will provide a forum to further implementation of innovative approaches to protect the quality of the product to the patient, and to prevent illicit acts such as counterfeiting, diversion, and economic adulteration from threatening the safety of the drug supply.
For more information, including press registration, go to www.pda.org.
Nominations Being Accepted for PDA Board of Directors
Bethesda, Md., April 4, 2014 – The Parenteral Drug Association (PDA) announced the opening of the nomination process for Board members for the 2015-2017 term.
“We do not want to miss outstanding members of our organization and strive for having a diverse Board of Directors,” says Anders Vinther, the current Nominating Committee Chair and Immediate Past Chair of PDA.
All PDA members are encouraged to nominate their peers within the Association for the Board of Directors election, although certain prerequisites are necessary. For example, only members in good standing can nominate and be nominated (that is, their membership is current).
The PDA Nominating Committee will consider all nominations and base their selection upon the following criteria: 1) status of membership; 2) level of activity within PDA; 3) volunteer history; 4) length of membership, and 5) diversity and relevant professional competences.
“When you nominate a candidate, please be so kind to include a brief explanation, which makes it easier for the selection committee to make their final choice,” requests Vinther.
To nominate, members can send an email to: nominate@pda.org. Nominations for the 2014 BoD elections will be accepted through June 13, 2014.
PDA Announces Opening Plenary Speakers for the 2014 Annual Meeting
Bethesda, MD., February 18, 2014 – The Parenteral Drug Association (PDA) is proud to announce that Dr. Mark B. McClellan, Director, Health Care Innovation and Value Initiative for the Brookings Institute and former FDA Commissioner and Dr. Rahul Singhvi, Chief Operating Officer, Vaccines, Takeda Pharmaceuticals International will be the Opening Plenary Speakers at the 2014 PDA Annual Meeting, April 7-9, JW Marriott San Antonio Hilly Country Resort & Spa in San Antonio, Texas.
Dr. McClellan’s work focuses on promoting quality and value in patient centered health care. As doctor and economist by training, he also has a highly distinguished record in public service and in academic research.
Dr. Singhvi has held several key positions in R&D and manufacturing with increasing responsibilities in the vaccine development process, including co-lead of the varicella-zoster virus vaccine project team that oversaw the development of Varivax®III (chickenpox vaccine), and Zostavax® (Shingles vaccine).
The 2014 PDA Annual Meeting will address the rapid changes in pharmaceutical manufacturing technologies that are occurring in response to new regulations, requirements and capabilities. This year’s theme is Biopharmaceutical and Sterile Manufacturing – Embracing Innovation to Meeting Global Challenges. It will include educational opportunities in the areas of biological sciences, product manufacturing and quality systems, which include over 60 presentations and case studies led by industry and regulatory leaders.
For more information, visit http://pdaannualmeeting.org. Press inquiries about registration should be directed to Richard Johnson, johnson@pda.org.
PDA Announces Elections Results
Bethesda, Md. - The Parenteral Drug Association announced the results of its 2014 Board of Directors and Officers Elections. All those elected begin their terms in January 2014.
Executive Committee
Hal Baseman, who served as chair elect, assumes the role of PDA Chairman of the Board for the term from 2014-2016.
Martin VanTrieste, Sr. Vice President, Quality, Amgen, was elected as Chair-Elect. Rebecca Devine, PhD, Regulatory Consultant, was voted in as Treasurer and Michael Sadowski, Director, Sterile Manufacture Support, Baxter, was elected to the position of Secretary.
Anders Vinther, PhD, Vice President, Quality Biologics, moves into the Immediate Past Chair position for the next two years.
Director Seats
PDA welcomes one new Director, Joyce Bloomfield, Executive Director, Global GMP Systems & Compliance, Merck, to the board.
Reelected are Jette Christensen, Aseptic Scientific Director, Novo Nordisk, and Glenn Wright, Senior Director, Project Management, Eli Lilly.
Returning to the Board is Veronique Davoust, PharmD, Manager, Global Quality Strategy, Pfizer, who previously served on the board 2008-2010.
Richard Johnson, PDA President and CEO offered his appreciation to outgoing members of the board.
“We would like to thank Maik Jornitz, Chief Operating Officer, G-Con, for serving as PDA Chair in 2010-2011 and as Immediate Past Chair 2012-2013. Additionally, we appreciate the hard work and service of Steve Mendivil, Executive Director, External Affairs, International Quality, Amgen, and Susan Schniepp, Vice President, Quality and Regulatory Affairs, Allergy Laboratories.”
PDA Courses Address Need for Knowledge of Aseptic Processing
Bethesda, Md. - Producing sterile products using aseptic processing technology is challenging and the FDA is aware of these challenges. Therefore the agency places a major emphasis on this area as part of its oversight responsibility.
One way to better produce sterile products is through training in aseptic processing, which is one of the cornerstones of the program offered through PDA’s Training and Research Institute.
In November and December 2013, the PDA Training and Research Institute will offer three courses in aseptic processing – including a new one designed especially for managers.
Quality Systems for Aseptic Processing (November 18 – 22)
This five-day comprehensive training program will give your personnel the tools necessary to optimize your Quality Systems associated with Aseptic Processing. Major topics covered include risk management, sterility by design, troubleshooting and solving sterile filtration issues, investigations and CAPA, and how to effectively implement change within a structured regulated environment.
Management of Aseptic Processing (December 4 – 6)
This course is intended for those in a management role with the responsibility for making business decisions related to aseptically produced products. The course will provide participants with the tools needed to make the difficult business decisions related to aseptic processing. They’ll come away with an understanding of the real costs of aseptic processing (running, maintenance, and compliance costs), what the alternatives are and what the future holds. The course will also provide the students with the knowledge needed to make informed, risk-based decisions.
Fundamentals of Aseptic Processing (December 16 – 20)
This course is intended to provide individuals with an understanding of the fundamental principles governing aseptic processing. It covers the systems associated with aseptic processing and how they work together to help ensure a sterile product. This course is ideal for those who are either new to the industry or new to aseptic processing. Mechanics, HVAC technicians, cleaning and disinfection personnel, and microbiology technicians will also benefit from this course even if they are minimally involved in the aseptic manufacture of drugs, but need to understand the systems associated with it.
Singapore Becomes Newest Chapter in Parenteral Drug Association
Bethesda, Md. – 45 pharmaceutical professionals have formed the Singapore chapter of PDA, bringing to 24 the number of chapters across the globe. In September, the group held its first official meeting with the following officers:
- President: Maureen Hertog, PharmD, Novartis Singapore Pharmaceutical Manufacturing Pte Ltd
- President-Elect: Sateesh Yelisetti, Baxter
- Treasurer: Chia Phei Kok, Visentic Solutions Pte Ltd
- Secretary: Wayne Lee, PhD, Pall
PDA/FDA JOINT REGULATORY CONFERENCE: Great Place to Learn From Regulators
Co-sponsored and co-planned by the PDA and the FDA, and held in Washington, D.C., the annual conference has become the place where those working in the pharmaceutical industry can join in discussions with representatives of the Food and Drug Administration to gain their perspectives. There were more than 45 FDA speakers, including Janet Woodcock, M.D., Director, CDER, FDA.
Attendees come from across the globe. Many say the conference gives them more than in depth knowledge to take back to their firms.
“In addition, for me as a lawyer, the many opportunities to hear directly from the FDA officials on what their current line of thinking is and what their visions on their expected policy changes are,’ said Daike Van de Putte, from GSK. “It was very insightful for me to learn the reasons behind such changes.
Other attendees, who supply the pharmaceutical industry, said the conference helped them better understand their customers.
“I came away with a deeper understanding of our customer's needs and challenges, critical information that enables us to become a better a partner,” said Ross. W. Acucena of EMD Millipore.
“The 2013 PDA/FDA Joint Regulatory Conference was, as always, a priceless venue to connect with colleagues and FDA representatives,” said Veronica Cruz, Ph.D., of Johnson & Johnson.
The 2014 PDA/Joint Regulatory Conference will is scheduled for September 8-10. There is a workshop, entitled 2014 PDA Drug Shortage Workshop on September 10-11. Courses from the renowned PDA Training and Research Institute will follow.
PDA Announces Changes In Membership Rates For Government Employees
Bethesda, Md., For government regulators across the globe, the Parenteral Drug Association is offering free or greatly reduced electronic membership fees.
“This change comes in recognition of the value that government employees add to PDA’s mission and to the economic challenges of joining professional associations,” said Richard Johnson, President, PDA.
The old membership rate for government employees was $100 per year. The new rate allows individuals employed by an official government organization to join for free in countries where it is allowed or pay $12 per year where a payment is required by their agencies.
The membership rate is not offered to firms or individuals who are contracted by government agencies.
Course Answers Questions About Single Use Systems
Single Use Systems for Manufacturing of Parenteral Products
Bethesda, Md., When the topic of single use systems comes up among pharmaceutical manufacturers, there seems to be more questions than answers.
On October 23 and 24, 2014, the PDA Training and Research Institute is offering a two day course that will give you a comprehensive guide to implementing a single use system. It includes how to implement a well-designed manufacturing strategy that will show you how a single use system can reduce costs and ensure quality products.
You’ll also be able to get your hands on products to see how they actually work and decide for yourself whether these would fit into your manufacturing process.
The course is offered at PDA’s Training and Research Institute in Bethesda, Maryland and taught by Robert Repetto, senior director, external affairs for Pfizer, Inc. He leads the company’s contract manufacturing strategy for biosimilars. He chairs PDA’s global task force for single use systems.
Parenteral Drug Association Elections Begin
Bethesda, Md., For members of the Parenteral Drug Association, this is election season – for open seats on the 2014 Board of Directors.
Three candidates are running for the officer positions on the Board. The candidates are Martin VanTrieste for Chair-elect, Rebecca (Becky) Devine for Treasurer and Michael (Mike) Sadowski for Secretary.
There are eight candidates seeking four open director seats. They are Joyce Bloomfield, EJ Brandreth, Veronique Davoust, Jette Christensen, Edwin Rivera Martinez, Morten Munk, Susan (Sue) Schniepp, and Glenn Wright.
The election will be conducted online at www.pda.org/vote. Polls open September 11 and close at 11:59 p.m. on November 15, 2013. Members can also vote on site at the following upcoming conferences:
| September 16-18 | 2013 PDA/FDA Joint Regulatory Conference | Washington, D.C. |
| October 7-8 | 2013 PDA Visual Inspection Forum | Bethesda, Maryland |
| October 21-23 | 8th Annual PDA Conference on Pharmaceutical Microbiology | Bethesda, Maryland |
| November 5-6 | PDA Universe of Prefilled Syringes & Injection Devices | Basel, Switzerland |
| November 13-14 | PDA/FDA Advanced Technologies for Virus Detection | Bethesda, Maryland |
The election is open to PDA members in good standing as of August 30, 2013 at 11:59 p.m.
Packaging Materials for Parenterals: Polymer – an Alternative to Glass?
Learn all about Packaging Materials for Parenterals: Polymer – an Alternative to Glass? At the Most Important Meeting of the Year!
Although Polymer as a container material for medicinal products has been accepted as an alternative to glass in certain regions and many applications, it is still not always seen as a first choice alternative for pre-filled syringes. However, development and acceptance of polymer as a packaging material has come a long way. Ten years ago, polymer was merely an exotic material for pre-filled syringes. Even though it was already well accepted e. g. in flexible bags (LVP) then, its use in prefilled syringe applications did not attract much attention.
In the last two years, however, the picture has changed dramatically. More possible applications have been presented, attracting quite a lot of interest. But still, polymer leaves many within the pharmaceutical Industry uncomfortable.
While glass syringes have a long and stable tradition, with benefits and restrictions well known, facts like breakage/ delamination and cosmetics, half-truths like permeability, extractables & leachables and costs of ownership have hindered the global market from adopting polymer pre-filled syringes as a valid and well-accepted alternative to glass. Offering new products and innovations in pre-filled polymer containers, the time is perfect now to review the current situation, evaluate the application of polymer for primary containers/pre-filled syringes and highlight possible advantages.
Two very well recognized pre-filled syringes specialists, William Dierick, Technology Development Manager at Terumo Europe N.V. and Dr. Wenzel Novak, Director pharm. R&D at Groninger & Co. GmbH, will chair a PDA Workshop in Basel on 4 November 2013 on "Polymer as a Container Material for Pre-filled Syringes” and will thoroughly discuss if Polymer is an innovative and most of all valid alternative to glass or just and expensive niche product.
When considering an alternative to glass it is essential to investigate all facts, identify possible problems and risks. The two workshop leaders will exactly do that in their workshop and discuss subjects like properties, prospects and market. They’ll look at existing systems and recent developments on polymer pre-filled syringes and even more advanced systems. They’ll share their experience with extractables & leachables and take a closer look at processing by using existing equipment or optimized equipment. William Dierick and Dr. Wenzel Novak will share their experience and give advice on getting the facts to overcome half-truths and rumors on polymers, on adopting these polymer-based systems for life-cycle management of existing drugs, and on launching new drug products in an optimized packaging configuration and will summarize the actual situation on the market, material options, concepts, benefits and retractions to using polymer syringes.
Highlights will be two interesting case studies on two established polymer systems in Japan and the USA and the experts will give an overview on available systems and upcoming polymer products. A comprehensive update on Regulatory issues regarding the usage of polymer as a packaging material for parenterals will bring this workshop to an adequate conclusion. Anyone working in development, fill-finish, quality assurance, regulatory affairs and marketing will get state-of-the-art information on polymer containers.
To counterbalance the subject packaging material for parenterals the training course "Glass – The Packaging Material for Parenterals" will be held on 7 November. The training course held by Dr. Bettine Boltres, Product Manager Pharmaceutical Tubing at SCHOTT AG, will review all aspects of "Glass - The Packaging Material for Parenterals”. Dr. Boltres will take a close look at the raw materials and production process of glass tubing, cover basics of physical and chemical properties of glass: the viscosity, coefficient of thermal expansion, chemical resistance, surface reactions, permeability, shelf life, glass breakage and defects. Drug container interactions such as extractables & leachables, pH shift, protein adsorption, lyophilization process and delamination will be analyzed closely. The glass expert will compare different types of type I glasses all around the world and will examine examples of problems like breakage or delamination and how to approach those challenges. Important regulatory issues will certainly be highlighted as well.
Both events will take place as part of the PDA Europe Conference "The Universe of Prefilled Syringes and Injection Devices - Providing Value and Compliance" in Basel, Switzerland on 5 November and 6 November 2013. The Universe of Pre-filled Syringes, has become THE must-attend meeting of the industry. Global experts will share and discuss the latest developments in all areas related to Prefilled Syringes. More than 95 exhibitors will present their latest innovations and developments in a large exhibition to approximately 600 participants from all-around the world.
Three plenary sessions will cover advances in health care, trends in pharmaceutical development and manufacturing and regulatory & compliance trends for drug devices. In six break-up sessions speakers will talk about and discuss with the participants topics like new developments, new techniques, user perspective, stoppers and elastomeric components, formulation challenges and manufacturing. Penal Discussions will give each participant the opportunity to actively discuss hot topics or to raise important questions.
Next to the above-mentioned workshop and training course, the conference will be accompanied by various training courses and an interest group meeting. The interest group meeting combination products on 4 November and the training course "Development and Technical Requirements for Combination Injection Products"on 7 and 8 November both held by Lee Leichter, President, P/L Biomedical will underline the importance of drug delivery combination products which are forecasted to become an increasing larger part of the marketplace for new drug and biologics as well as for lifecycle management, generics and biosimilars. A two-day training course on 7 and 8 November will give a holistic overview on the "Development of a Pre-filled Syringe".
The "Universe of Pre-filled Syringes and Injection Devices" is one of the most influential meetings in the industry organized by PDA Europe. The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. PDA is the recognized authoritative voice and leading technical organization in the field of parenteral science and technology. Through the development of Technical Reports and responses to regulatory initiatives, PDA and its members influence the future course of pharmaceutical products technology.
INTERPHEX and PDA Announce Agreement
NORWALK, CT, Aug. 19, 2013 – International Pharmaceutical Expo (INTERPHEX), the leading annual trade event dedicated to the pharmaceutical and biopharmaceutical industry and the Parenteral Drug Association (PDA) are pleased to announce a three-year Sponsorship Agreement. This Sponsorship aligns the objectives of both organizations to service key needs of the global pharmaceutical and biopharmaceutical industry by driving innovation and advancement.
INTERPHEX serves as a strong platform for decision-makers in the pharmaceutical and biopharmaceutical manufacturing community, bringing together over 12,000 industry professionals to learn, network and source from the latest technology, equipment, education and services. PDA is the premier global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical industry. Its mission is to develop scientifically sound, practical technical information and resources to advance science and regulation for the pharmaceutical and biopharmaceutical industry through the expertise of its more than 9,500 global members.
"Our Sponsorship of INTERPHEX reflects our support of the continued enhancement of industry learning and improvement, areas we find present at INTERPHEX," stated Richard Johnson, President and CEO of PDA. "Non-profits and corporate entities can work together to leverage best practices, in real-time, to the benefit of our industry. Our collaboration with INTERPHEX is one example of this effort and we are pleased to move forward in this shared endeavor."
PDA will be directly involved in developing the INTERPHEX conference programming identifying speakers from industry and regulatory agencies and developing a PDA sponsored cGMP Track. PDA members will have extensive educational and networking opportunities including an exclusive Association Membership Lounge.
"A long-term Sponsorship with PDA, both on national and global levels, aligns us with thought leaders across the globe," stated Bob Stewart, Vice President of INTERPHEX. "By fostering alliances with successful non-profit organizations like PDA, we acknowledge our investment in the future of the biopharmaceutical industry, and ultimately deliver unrivaled opportunities for knowledge, interaction, and professional growth."
INTERPHEX will be held March 18-20, 2014 at the Jacobs Javits Center in New York City, NY
About INTERPHEX
International Pharmaceutical Expo (INTERPHEX) is the world's most trusted forum for leading-edge technology, education and sourcing of equipment, products and services that improve manufacturing and supply chain performance for pharmaceutical, biologic, generic and service provider professionals. It brings pharmaceutical and biotechnology professionals together with suppliers through a unique combination of conference, exhibition, workshops, partnering opportunities, and networking events. For information, visit www.INTERPHEX.com and follow INTERPHEX on Facebook, LinkedIn and Twitter (@INTERPHEX.)
Press Contacts
Lauren Laramore
Director of Marketing, INTERPHEX
T: 203-840-5958
Email: llaramore@reedexpo.com
Amelia Townsend
Director of Marketing Services, Parenteral Drug Association® (PDA)
T: 301-656-5900, ext. 153
Email: townsend@pda.org
FDA’s Rick Friedman and Rebecca Rodriguez Confirmed as Closing Plenary Speakers for PDA Human Factors Workshop
Bethesda, Md., February 1, 2012 – The Parenteral Drug Association (PDA) announced today that Richard Friedman,Associate Director OMPQ, U.S. FDA, and Rebecca Rodriguez, Consumer Safety Officer, U.S. FDA, have been confirmed to deliver the closing plenary talks at the 2013 Human Factors and Human Error Reduction Workshop. The workshop will take place on April 17 – 18, 2013 at the Peabody Hotel in Orlando, Fla.
“PDA continues Connecting People, Science and Regulation® by offering high-quality, technical workshops with the cooperation of officials from the FDA and other regulatory bodies worldwide,” said Richard Johnson, PDA President and CEO. “In 2013, we are hosting seven conferences and workshops with the FDA on topics critical to pharmaceutical manufacturers, like glass packaging, supply chain and internal investigations. The 22nd annual PDA/FDA Joint Regulatory Conference stands out as the longest running, co-hosted meeting with FDA on GMP and other QA/QC and manufacturing topics. In addition, FDA officials like Mr. Friedman and Ms. Rodriguez continue to participate in our other meetings, like the Human Factors Workshop and the Annual Meeting.”
The workshop will introduce the audience to the science of human factors and will illustrate the significant role and impact human factors has made in other industries ranging from aviation to nuclear control rooms. Following this brief introduction, the audience will participate in interactive sessions to learn how to use various human factors tools to help assess, understand and utilize the information needed to address manufacturing performance and/or safety concerns in processing and manufacturing facilities.
Friedman and Rodriguez serve as the closing bookend to an event that begins with Keynote Speaker Dr. Najmedin Meshkati, Prof. of Civil/Environmental Engineering and Industrial Systems Engineering at the Viterbi School of Engineering, University of Southern California. In between, sessions featuring case studies will be shared by the moderators to highlight potential areas of concern, and how these areas have been improved through the use of human factors tools and techniques, resulting in improvements of operations, layout, workflow and overall system design. Speakers from Amgen, Radius Product Development and Abbott Medical Optics are already confirmed.
More information on the workshop is available at http://www.pda.org/humanfactors2013.
PDA Announces Establishment of New Chapter in Texas
Bethesda, Md., February 1, 2012 – The Parenteral Drug Association (PDA) is proud to announce the founding of the PDA Texas Chapter, which will serve PDA members in that area.
"PDA has a long history of members in Texas and we are excited to introduce the PDA Texas Chapter. The area has a great mix of established pharma/bio industry, and is becoming a hub of new development, especially in new therapies. We anticipate the PDA Texas Chapter will help members access important information about evolving technical and regulatory issues, and serve as a valuable networking nucleus," said PDA President Richard M. Johnson. He added, "The importance of high quality, innovative, and cost effective therapies has never been greater, and together we can continue to connect people, science and regulation. PDA is honored to have such overwhelming interest from the community and we look forward to working with active members in the region."
The initial chapter leadership will include PDA members and industry leaders: Beth Kirschenheiter of Hospira will serve as the first Texas Chapter President. She will be joined by, Chapter Treasurer Winston Brown, Alcon and Chapter SecretaryPatricia Rossman, Globiox.
For more information, contact PDA Chapter President Beth Kirschenheiter, beth.kirschenheiter@hospira.com. Press inquiries should be directed to PDA's Walt Morris, morris@pda.org.
PDA Establishes the Martin VanTrieste Pharmaceutical Science Award
“Long standing PDA member and Board Member, Martin VanTrieste has been a great contributor to PDA in many ways. His leadership, knowledge and participation in PDA’s Science Advisory Board, multiple program planning committees and his input regarding critical scientific documents has been a great asset to our community,” said PDA President, Richard M. Johnson. He added, “Martin is a dedicated PDA member who freely has shared his knowledge to advance the mission of PDA. We look forward to awarding others who show the same dedication as Martin has.”
The Martin VanTrieste Pharmaceutical Science Award will be awarded annually for Outstanding Contributions to the Advancement of Pharmaceutical Science for the Parenteral Drug Association.
Press inquiries should be directed to PDA’s Adrienne Fierro, fierro@pda.org.
PDA Announces the Results of the 2013 Board of Directors and Officers Election
PDA is pleased to announce the results of the 2013 Board of Directors election. The elected candidates will fill their term beginning on January 1, 2013. Thank you to all who voted!
Directors:
The PDA Board of Directors welcomes new board members, Ian Elvins, Lonza AG, and Stephan Rönninger, Roche as well as re-elected board members Gabriele Gori, Novartis Vaccines and Diagnostics and Lisa Skeens from Hospira, Inc.
PDA would like to extend a sincere thank you toZena Kaufman, Hospira, Inc. and Martin VanTrieste, Amgen for their years of service on the PDA Board of Directors.
More information is available in the January issue of the PDA Letter.
PDA Announces the Results of the 2013 Election
PDA is pleased to announce the results of the 2013 Board of Directors election. The elected candidates will fill their term beginning on January 1, 2013. Thank you to all who voted!
Directors:
The PDA Board of Directors welcomes new board members, Ian Elvins, Lonza AG, and Stephan Rönninger, Roche as well as re-elected board members Gabriele Gori, Novartis Vaccines and Diagnostics and Lisa Skeens from Hospira, Inc.
PDA would like to extend a sincere thank you toZena Kaufman, Hospira, Inc. and Martin VanTrieste, Amgen for their years of service on the PDA Board of Directors.
More information is available in the January issue of the PDA Letter.
PDA’s New Technical Report Portal is Now Open!
“This is the most innovative and significant member benefit ever offered by The Parenteral Drug Association (PDA),” said Richard M. Johnson, PDA President. “We have been working hard on enhancing our member value and we believe that releasing this new Technical Report Portal by the end of 2012 is a breakthrough benefit that you just don’t see anywhere. Most associations charge a premium for their technical documents, but we see benefit in helping our members access relevant technical information when they need it and at no extra cost to them.”
PDA Technical Reports are highly valued, global technical documents prepared by member-driven Task Forces comprised of content experts, including scientists and engineers working in the pharmaceutical and biopharmaceutical industry, regulatory authorities and academia.
We are allowing all PDA Technical Reports to be viewed through our new portal to current PDA Standard and Government members. After the login process with member credentials, members will be able to view the Technical Report documents (but not print, share or copy these documents).
PDA members will continue to be able to download a print version of a newly released technical report free of charge within 30 days of publication as part of their membership benefits. For more information please visitwww.pda.org/trarchive.
PDA Announces Establishment of New Chapter in India
“This is a critical time in the global pharmaceutical marketplace and we are excited to introduce the PDA India Chapter. There is no doubt about India’s evolving importance in the market and we believe that now is the perfect time to help support this critical region,” said PDA President Richard M. Johnson. He added, “Market diversity is on the rise, business opportunities have been established, affordability of drugs and accessibility is at a critical point and India is a major player in this changing landscape. PDA is honored to have such overwhelming interest from the community and we look forward to working with active members in the region.”
The initial chapter leadership will include PDA members and industry leaders: Sanjay Singh of Aurobindo Pharma. will serve as the first India Chapter President. He will be joined by Chapter President-Elect Sanjit Singh Lamba, Eisai Pharmatechnology & Manufacturing, Chapter Treasurer Ivy Louis, Vienni Training & Consulting and Chapter SecretaryAmit Sharma, Sartorius India.
For more information, contact PDA Chapter Secretary Amit Sharma, Amit.Sharma@Sartorius-Stedim.com. Press inquiries should be directed to PDA’s Adrienne Fierro, fierro@pda.org.
About PDA:
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide.
PDA Announces New Technical Report (TR) Portal by the End of 2012
"This is the most innovative and significant member benefit ever offered by The Parenteral Drug Association (PDA)," said Richard M. Johnson, PDA President. "We have been working hard on enhancing our member value and we believe that releasing this new Technical Report Portal by the end of 2012 is a breakthrough benefit that you just don't see anywhere. Most associations charge a premium for their technical documents, but we see benefit in helping our members access relevant technical information when they need it and at no extra cost to them."
PDA Technical Reports are highly valued, global technical documents prepared by member-driven Task Forces comprised of content experts, including scientists and engineers working in the pharmaceutical and biopharmaceutical industry, regulatory authorities and academia.
We are allowing all PDA Technical Reports to be viewed through our new portal to current PDA Standard and Government members. After the login process with member credentials, members will be able to view the Technical Report documents (but not print, share or copy these documents).
PDA members will continue to be able to download a print version of a newly released technical report free of charge within 30 days of publication as part of their membership benefits. For more information please visitwww.pda.org/trarchive.