Press Releases (Card Grid)

Berlin (October 23, 2009) – The European Medicines Agency (EMEA) told industry manufacturing, control and regulatory professionals gathered at the 2009 PDA/EMEA Joint Conference that complicated  supply chains, while necessary, are a weak link in quality control.

Opening plenary session speakers from the EMEA and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) outlined a number of interconnected challenges that are applying increasing pressure on the ability of both manufacturers and health authorities globally to safeguard the quality of pharmaceutical products.

Katrin Nodop, an EMEA Inspections Section representative, noted that the European Agency is working earnestly on partnerships with regulatory agencies in other regions to get a better grip on the growing challenges. One tool the EMEA uses is confidentiality arrangements, currently in effect with the U.S., Japanese and Canadian authorities. Nodop said, “Slowly, slowly our own priorities shift from the European perspective to the global one.”

To be effective in the future, the EMEA will seek methods of strengthening communication, collaboration and cooperation with industry and other health authorities. “We need to have proper arrangements so we can rely on the local regulators to do their work,” Nodop said in reference to countries like China and India which are now major suppliers of both active and inactive ingredients to drug manufacturers in Europe. The EMEA will “try to contribute to assist them through training and the exchange of staff to improve their regulatory capacity.”

Gerald Heddell, Director of Inspections, Enforcement & Standards, MHRA, UK, noted that changes in the economic environment and the escalating cost of R&D will only accelerate the trend towards outsourcing to India, China and other developing economies, about which he said, “I believe that many third country suppliers are responsible, well-managed companies, but recent experience reminds us that we need to be vigilant. And the further away, the more remote our sources of supply are, the more that vigilance is necessary.”

A number of other health authorities were represented at the two-day conference, including the Laboratoire National de Sante (Luxembourg), the Irish Medicines Board, the States Agency of Medicines (Latvia), the Agence Francaise de Securite Sanitaire des Produits de Sante (France), and the conference host country’s Regierungsprasidium Darmstadt.

The EMEA and PDA agreed to hold a fourth joint conference in 2011, following the 18-month schedule established at the first conference in 2006. The two organizations mentioned the possibility that the conference would become an annual event after 2011.

Bethesda, Md. – U.S.  FDA Deputy Commissioner Joshua Sharfstein, MD, previewed what direction the Agency’s public health policies will take under new Commissioner Margaret Hamburg, MD, during his keynote address at the 2009 PDA/FDA Joint Regulatory Meeting in Washington, D.C. on September 14.

Sharfstein presented four principals that will guide FDA’s new approach: prevention, best available science, transparency and that the idea of the premise of public health is that what matters is the health of the public.

“In evaluating product quality issues for 2020, I would imagine there are many potential ways to resolve key challenges—I urge you to consider the health of the public as the North Pole for your compasses.”

He noted the importance of partnering with the agency to better serve the public and advised PDA members to tap into the resources available at FDA to further innovative efforts. “We hope to see many productive and creative efforts where the agency can share its knowledge and expectations, and we can foster a new generation of safe and effective medical products for the American people.”

Sharfstein said that he and Dr. Hamburg were “impressed” with “efforts involving the International Conference on Harmonisation, global regulators and industry.” He said, “the goal of these efforts is to understand from the start what makes a product of high quality … rather than waiting to discover that after the fact.  We would like to foster more such productive collaborations that lead to concrete results in preventing problems.”

Earlier in his speech, Sharfstein told members that, “at FDA, Dr. Hamburg and I understand that product quality issues also rest on a base of  regulatory science.” He said that the Commissioner is encouraging leading scientists at the Agency to identify “key projects that, if supported, can improve product quality and streamline approval pathways—making them at once quicker and more reliable.”

After his keynote address, the Deputy Commissioner participated in a press conference, where members of the trade press were present.

For the complete transcript of Sharfstein’s remarks go to http://www.pda.org/pdafda2009

Bethesda, Md. – The Parenteral Drug Association, Inc. (PDA) has announced the appointment of Richard M. Johnson as the Association’s next President, effective September 2009.

The search for a new president began when former President Robert Myers announced his intention to retire in late 2008.  PDA created a presidential search committee, comprised of members of the Board of Directors and association members at large, to conduct the search process. There was a strong response to the call for applications made early in 2009, with candidates for the position interviewed first by phone and then in person by the search committee and senior members of the Association’s staff.  Based on the feedback from these interviews the Board of Directors unanimously endorsed Johnson to be the next president.

PDA Chair John Shabushnig announced the appointment to PDA staff on Wednesday August 26. “PDA is delighted to have selected a new president who brings both strong technical and regulatory understanding to the position, along with a demonstrated ability to lead both large and small organizations. He has been an active volunteer and is well known to the membership. I have personally enjoyed working with Richard on the PDA Science Advisory Board, and I know he will demonstrate the same open style and enthusiasm in his new role.”

Johnson has over thirty years of experience in pharmaceuticals and medical devices, working for Abbott Laboratories, Fort Dodge Animal Health, Alcon Laboratories, and most recently as a consultant.  Johnson currently serves on PDA’s Science Advisory Board (SAB), and over his 15 years as a PDA member, he has been active in the Association’s Interest Groups and conferences and has published commentary articles in the PDA Journal of Pharmaceutical Science and Technology.

He was a key leader in PDA’s effort to work with the U.S. FDA to develop a revised guidance on aseptic processing of sterile pharmaceutical products earlier this decade. The result of PDA’s efforts was the formation of a working group in the FDA-supported Product Quality Research Institute (PQRI) which provided a number of recommendations to the FDA, many of which were ultimately incorporated into the final guidance published in 2004.

On joining the staff of the Association for which he has long volunteered, Johnson says “It is an honor to become a member of the PDA team, and I look forward to working together to advance the goals of the organization and members.”

Johnson’s first public appearance to PDA members in his new role will be September 14 at the upcoming PDA/FDA Joint Regulatory Conference in Washington, D.C.

Bethesda, Md. – Something unique to the long-running PDA/FDA Joint Regulatory Conference will occur this year. Not only will the meeting delve deeply into the most pressing regulatory issues of the day, but its closing day will include a powerful reality check when regulatory affairs professional and breast cancer survivor Amy Giertych provides her unique perspective as both an insider and a patient.

The senior director of Baxter’s Global RA will discuss her experience as a patient, a professional and a consumer of the life-saving medicines the industry manufactures.

The closing sessions of the 2009 PDA/FDA Joint Regulatory Meeting also willfocus on the U.S. FDA’s future compliance expectations. The final session will provide the perfect point of departure for attendees, as officials within the FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), and Center for Veterinary Medicine (CVM) will provide brief updates about current initiatives within their areas of expertise and will participate in a closing panel discussion.

The following Agency members have been invited to speak at this session:
Deborah Autor, Director, Office of Compliance (CDER)
Mary Malarkey, Director, Office of Compliance and Biologic Quality (CBER) 
Timothy Ulatowski, Director, Office of Compliance (CDRH) 
Daniel McChesney, Director, Office of Surveillance and Compliance (CVM) 
Steven Silverman, Assistant Director, Office of Compliance (CDER) Joeseph Famulare, Deputy Director, Office of Compliance (CDER)Richard Friedman, Director, Division of Manufacturing and Product Quality (CDER)

Bethesda, Md. - Officials from the Shanghai Institute of Food and Drug Safety (SIFDS), a branch of the Shanghai Municipal Food and Drug Administration (SHFDA), and the Parenteral Drug Association, Inc. (PDA) celebrated the grand opening of a new office for the SIFDS/PDA Joint Development Center (SHJDC). The opening comes just nine months after PDA and SIFDS inked a Memorandum of Understanding that outlined a cooperative arrangement to facilitate information exchange and sharing.

Tang Minhao, deputy director, and Yan Liang, director of legal and international affairs, of the SHFDA, Xu Lai, director of the SIFDS, and Robert Myers and Richard Levy from PDA participated in the grand opening ceremony.

PDA President Robert Myers said at the ceremony, “Working with the SHFDA and the SIFDS is in line with PDA’s Vision to be the foremost global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical industry.”

Afterwards, Myers said, “It was truly an exciting moment for me to be witness to the opening of the SHJDC office, coming at the conclusion of our first two-day meeting in partnership with the SIFDS. I’m confident that this collaboration will continue to grow and contribute to the enhancement of quality and technology in China’s pharmaceutical industry for years to come.”

The opening ceremony came on the heels of the two-day 2009 PDA/FDA Asia-Pacific Pharmaceutical Supply Chain Conference, the first joint meeting held between PDA and the SIFDS under the September 8 Memorandum of Understanding. On June 15 and 16, pharmaceutical professionals from industry and the SHFDA gathered to hear presentations on best practices in pharmaceutical supply chain manufacture and control. This event also marked the last in a successful series of meetings PDA and the U.S. FDA held worldwide on the topic beginning in September 2008 in Washington, D.C.

Following the SHJDC opening ceremony, PDA, SIFDS and the SHFDA officials met to debrief on the two-day meeting and to plot the future course of the collaboration.

The overall impression of the meeting was positive. SHFDA official Tang Minhao expressed his satisfaction with the meeting, noting it established a solid foundation for the future. He indicated that the Chinese government was committed to providing support for future PDA programs with the SHFDA.

PDA Senior Vice President Richard Levy stated, “Based on our successes so far, we agreed to expand our educational efforts for 2010 by co-organizing two meetings, one focused on manufacturing sciences and the other on quality and regulatory issues of interest to China. PDA’s Wanda Neal’s leadership in managing the meetings in cooperation with the SIFDS staff will contribute to our success next year, as it did in 2009.”

SIFDS’ Lai noted that the PDA and her organization achieved seamless assistance and cooperation in setting up and executing the supply chain conference. The SHFDA would like to continue to discuss the overall cooperative program and further areas of collaboration, she said.

Joining Tang, Lai and Liang from the SHFDA at the ceremony were Chengdong Yi, deputy director.

Joining Myers and Levy from PDA were Robert Dana, senior vice president training and education, Wanda Neal, vice president, programs and meetings; Nahid Kiani, vice president, sales and membership; and Hal Baseman, PDA Board of Directors (ValSource LLC).

A representative of the U.S. FDA, Steven Wolfgang, consumer safety officer, also attended the festivities and spoke at the meeting.

Bethesda, MD – The Parenteral Drug Association (PDA) reached a membership and information-sharing agreement with its chapter in Taiwan, which closely supports the Taiwan FDA (TFDA).

The agreement provides the TFDA access to PDA’s technical information for internal use. All members of the PDA Taiwan Chapter, approximately 500 professionals, are officially joining the Global PDA and membership is extended to 9 executives of the TFDA and one executive of the IDB. This arrangement ensures that the PDA scientific information used by industry and regulators in Taiwan will be current and at the high standard established by the Global PDA Organization.

On April 21, 2009 at the PDA Annual Meeting in Las Vegas, the agreement was signed by TPDA President Shin-Yi Hsu and Chapter Secretary General Tuan-Tuan Su and  PDA President Robert Myers and PDA Chair John Shabushnig.

“I am very pleased to see this effort brought to fruition,” said PDA President Myers. “We have worked with the Chapter on this agreement for a period of time and now we can move forward and ensure that the industry in Taiwan can benefit from PDA’s high quality technical materials.”

“This agreement helps solidify the close relationship between PDA and the Taiwan Chapter,” said PDA Chair John Shabushnig. “It also opens the door to closer relations between the global PDA organization and the Taiwan FDA.”

The agreement grants members in Taiwan electronic access to PDA’s International Pharmaceutical Quality, the PDA Letter, all completed PDA Technical Reports, and the PDA Journal of Science and Technology, including the right to translate documents.

Bethesda, Md. - The Parenteral Drug Association (PDA) has confirmed three keynote speakers for the 2009 PDA/FDA Joint Regulatory Conference who will discuss what the year 2020 will look like for the industry and what challenges must be overcome for the pharmaceutical industry, especially in the manufacturing segment of the industry.

Michael Bonney, President and CEO, Cubist Pharmaceuticals, Jacqueline Scott, Professor Harrison Institute for Public Law, Georgetown University, and Barbara Ryan, Analyst, Deutsche Bank will get the meeting started with their expert opinions on where they expect the industry to be in 2020. Specifically, Scott will be presenting about views on public policy as it pertains to 2020; and, Ryan will be speaking about the financial analyst perspective on the pharmaceutical industry.

From September 14 -16, hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance. Each year at this PDA signature conference, FDA speakers provide updates on the development of global regulatory strategies; while industry professionals from some of today's leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.

To learn more about the conference, visit www.pda.org/pdafda2009

Bethesda, Md. - In January 2009, Robert L. Dana, a long time PDA member, assumed new responsibilities within PDA.  In his new role as Senior Vice President, Regulatory Affairs and Training and Research Institute, he will report to Bob Myers, President of PDA, and will also maintain a dotted line relationship to Rich Levy, PhD, Sr. VP, Scientific and Regulatory Affairs, PDA and will continue to serve as PDA’s regulatory authority.

In his previous position as Vice President, Quality and Regulatory Affairs, Bob worked with key regulators in the U.S. FDA, EMEA and Japan; as well as serving as a staff liaison to PDA’s Regulatory Affairs and Quality Committee.  He will continue to be responsible for these activities in his new position.

He has also been an instructor for TRI courses and training functions and has worked closely with TRI staff to help identify several course offerings in the current curriculum.

In addition to his experience on the PDA staff, Dana has over 35 years experience in product development, quality, compliance and regulatory affairs, both in private industry and as an independent consultant.  He is a former member of the PDA Board of Directors.

Myers said that he expects TRI to continue to be a flagship operation, and build on its unique training capabilities at selected sites around the U.S., as well as at the unique first class Bethesda facility that enhances PDA’s hands-on laboratory training. Myers predicts that TRI will have record attendance in its Aseptic Processing Training Program in 2009, noting that the first three sessions are already sold out.

According to Myers, TRI is also in the process of conducting training for reviewers in FDA’s division of Manufacturing & Product Quality within CDER.