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Richard M. Johnson is president of the Parenteral Drug Association.
PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.
PDA has thousands of members who spend a great deal of their time tracking regulatory requirements around the world and communicating with regulators about quality and GMP issues. Over PDA's long history, the membership has found that coming together through the association to participate in the regulatory process was an effective and preferable way of communicating with the regulatory bodies. Many members volunteer to serve on committees to develop comments.
This regulatory activity is embodied in the third element of PDA's 2010 Strategic Plan, which states: "REGULATION— Our regulatory activities are scientifically and technically focused, and current information is communicated to our members." This is further defined with four criteria, the first two calling for: 1) the provision of science- and technology-based input on regulations and guidelines related to PDA strategic areas, utilizing PDA's volunteer and membership base, and; 2) maintaining valuable and effective relationships with global regulators, and educate members on current expectations.
Over the past two decades, PDA's membership has moved beyond just commenting on new regulations and guidance. Through hard work and careful planning, PDA has been able to host joint conferences with regulators, provide specialized training to regulatory authorities, and include regulatory officials in its processes for developing technical reports. These closer forms of cooperation all started with PDA's involvement with the US FDA regulatory process, which led to the creation of the PDA/FDA Joint Regulatory Conference nearly a quarter of a century ago.
It did not take long for this conference to become one of the most important annual events hosted by PDA for its membership. Attendance at the meeting grows each year, as does the number of attendees and speakers representing not just FDA, but regulatory bodies from around the world.
Over the years, the PDA/FDA Joint Regulatory Conference has focused on key topics important to the agency and the industry, including aseptic processing, GMPs for the 21st Century, ICH topics, and supply chain. This year's event is no different with the focus on implementing and advancing a sustainable global quality culture. Sessions have been tailored so attendees receive updates on global regulatory strategies from speakers representing FDA and other regulatory bodies and practical take-home strategies on how to meet the regulatory challenges from industry speakers. Following the meeting, the PDA Training and Research Institute will host a number of courses on similar topics for those who need to drill deeper.
A highlight of the 2012 PDA/FDA Conference is the post-conference workshop, Responsibilities of Executive Management (Operations and Quality)—Implementing the Principles of ICH Q10 2012 PDA/FDA Pharmaceutical Quality Systems. This event is designed to provide senior management and operations personnel an understanding of the framework established by ICH Q10 for the creation of an efficient and robust quality system that meets regulatory expectations around the world.
In recent years, PDA and FDA have increased the number of cosponsored events held annually to provide more focused attention to hot-button issues like supply chain and pharmaceutical glass quality. The hard work and outreach of PDA's European members has formed bridges with regulators throughout Europe as well, and the formation of the European equivalent to the PDA/FDA Joint Regulatory Conference—the PDA/EMA Conference, which has been held approximately every other year since 2005. It will be held next in December 2012.
Over the last decade, PDA's focus has been on building relationships with regulators throughout the world to meet the needs of our members globally. We held a PIC/S workshop earlier this year and have had meetings and trainings with regulators from Japan, Kazakhstan, Russia, and many others.
It is these activities that exemplify the membership's tireless focus on "Connecting People, Science and Regulation."
Richard Johnson is president of the Parenteral Drug Association (PDA).