The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
Please find below information about many exciting upcoming meetings:
1. DIA/FDA: Biosimilars Conference: Guidances, Science, and BsUFA
This conference will deal with the scientific and regulatory issues related to the demonstration of biosimilarity, focusing both on the FDA’s current thinking on approaches to biosimilar development as well as perspectives of other regulators. The FDA guidance will be discussed from the perspectives of regulators and industry.
Date/location: September 12-13, 2012, in Washington DC.
Additional Information: DIA/FDA: Biosimilars Conference
2. FDA Small Business Regulatory Education for Industry (REdI) Conference Fall 2012
The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our intended audience is the small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices.
Date/location: September 19-20, 2012 in Washington DC.
Additional Information: FDA Small Business REdI Conference Fall 2012
3. GDUFA Public Meeting
The purpose of the public meeting is to discuss recent communications concerning GDUFA implementation and to provide an opportunity for the public to present views on these materials.
Date/location: September 23, 2012, in Silver Spring MD.
Additional Information: GDUFA Public Meeting
4. FDA/European Medicines Agency Orphan Product Designation and Grant Workshop
The FDA Office of Orphan Products Development is announcing this 1-day workshop, which is intended to provide valuable information about the FDA and European Medicines Agency (EMA) Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD) Designation program, the FDA Orphan Products Grant program, and the European Union (EU) rare disease research programs to participants representing pharmaceutical, biotechnology, and device companies, as well as academics.
Online registration for the workshop will be limited to 240 participants for the morning session, of which approximately 30 teams (up to 90 participants) may register for the one-on-one sessions. There will be no registration fee for the workshop.
Date/location: October 12, 2012, in Silver Spring MD.
Additional Information: FDA/EMA Agency Orphan Product Designation and Grant Workshop
5. DIA/FDA Industry PDUFA V Conference
This meeting will provide an opportunity for FDA, industry, patient, consumer, and healthcare professional group representatives, and technology vendors to discuss the key PDUFA V commitments, current plans for their implementation, and potential impact on all stakeholders
Date/location: October 18-19, 2012, in Arlington, VA.
Additional Information: DIA/FDA Industry PDUFA V Conference
6. DIA/FDA: Revitalizing Productivity in Drug Development
The focus of this conference is to review the status quo of pharmaceutical industry and to explore the initiatives that champion the continued revitalization of R&D productivity in drug development. This conference will provide a forum for industry, regulators and academia to come together to discuss challenges and opportunities, and to share visions, experience, and lessons learned. This conference will stimulate open dialogue between industry and regulators, and ultimately, will help enhance efficiency and right decision making in drug development.
Date/location: October 23, 2012, in Bethesda, MD.
Additional Information: DIA/FDA: Revitalizing Productivity in Drug Development
7. FDA Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop
FDA, Baltimore District Office, in co-sponsorship with the Society of Clinical Research Associates (SoCRA), is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of the FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulation, relating to drugs, devices, and biologics; as well as inspections of clinical investigators, of IRB, and research sponsors.
Date/location: November 14 and 15, 2012, in Baltimore MD.
Additional Information: FDA Clinical Trial Requirements, Compliance, and Good Clinical Practice
Additional meetings: http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM.
- Email: CDERSmallBusiness@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/smallbusinessdrugs
- Widget: http://www.fda.gov/Drugs/ucm153379.htm
Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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