FDA & PDA Work to Align Manufacturing Goals with Patient Needs
On Tuesday March, 22nd FDA announced a public conference, entitled “Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance,” to be held in co-sponsorship with the Parenteral Drug Association (PDA).
FDA and PDA hold an annual Joint Regulatory Conference, which provides a unique opportunity for participants to engage with FDA representatives and industry experts in face-to-face dialogue. Each year, the conference focuses on the “current issues affecting the industry,” and explores different strategies to expedite the development and continuous improvement of safe and effective medical products.
The conference helps ensure the quality of FDA-regulated products by helping to achieve the objectives set forth in section 406 of the FDA Modernization Act of 1997. These objectives include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public.
During the conference participants will have the chance “to discuss the foundations, emerging technologies, and innovations in regulatory science, as well as the current quality and compliance areas of concerns.” Participants will hear from a number of speakers from the industry as well as representatives from the Agency who will delve into the “requirements and best practices to consider while implementing robust quality systems in order to deliver the best quality product.” The topics that will be discussed throughout a series of sessions and meetings include, but are not limited to:
- Product Quality
- Data Integrity
- Breakthrough Therapies
- Quality Metrics/Quality Culture
- Quality Systems
- Case Studies for Quality
- Quality Submissions
- Prescription Drug User Fee Act
- Supply Chain
- Quality Risk Management Systems
- Human Factors
- Patient Perspective
- Compliance Update
- Center Initiatives—Regulatory Submission Update
The 2016 FDA-PDA Joint Regulatory Conference will be held from September 12 to 14, 2016 at the Renaissance Washington DC Downtown Hotel. Registration is required, and those interested in attending the conference are encouraged to register as soon as possible, as space is limited and on a first come first served basis. On-site registration will be offered as space allows and will begin at 1pm on September 11, 2016, and at 7am from September 12 through 14, 2016.
To learn more or to register online, visit the PDA’s website.