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Who are RQA

The research quality association (RQA) is a professional membership body dedicated to informing and advancing its members. We provide status and visibility for individuals engaged in the quality of research concerning pharmaceuticals, agrochemicals, chemicals and medical devices. Since our inception in 1977, the Association has increased and evolved to reflect regulatory changes, the growing impact of regulatory inspection and the ever-changing structure and needs of industry.
RQA's purpose is to drive quality and integrity in scientific research.

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Our Mission

1. To develop and promote quality standards in scientific research.

2. To facilitate knowledge sharing and transfer through:

  • Discussion
  • Training
  • Seminars
  • Forums 
  • Conferences
  • Publications
  • Partnership and co-operation

3. To liaise with regulatory agencies in the development and interpretation of regulations and guidance.

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Latest News

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FDA Announces Availability of Draft Guidance on Electronic Records and Electronic Signatures in Clinical Investigations

20th June 2017 FDA is announcing the availability of a draft guidance for industry entitled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11-- Questions and Answers.” The draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products. The draft guidance clarifies, updates, and expands upon recommendations in the 2003 part 11 guidance for recommendations that pertain to FDA-regulated clinical investigations conducted under parts 312 and 812. Thus, the guidance is limited to the scope and application of part 11 requirements to such clinical investigations. The goals of the draft guidance are to clarify and update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations and to encourage and facilitates the use of electronic records and systems to improve the quality and efficiency of clinical investigations. The guidance discusses the procedures that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and are considered to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. The guidance also discusses the use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations conducted under parts 312 and 812. More information on how to comment on this draft guidance can be found in the Federal Register Notice: https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-12811.pdf

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Sarah Haig - Lost with the letter Q

The search for Sarah continues...

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EMA - Entry into application of EU Clinical Trial Regulation postponed to 2019

The EMA Board discussed the progress made regarding the development of the EU clinical trial portal and database. Due to technical difficulties with the development of the IT systems, the portals go-live date has been postponed.

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Sr. Associate Global Quality & Compliance - R&D

Location: Zaventem, Belgium

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