News Archive

Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

26th July 2017

This is the first revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’. It extends the existing EU guidance to address first-in-human (FIH) and early phase clinical trials (CTs) with integrated protocols. The revision is intended to further assist stakeholders in the transition from non-clinical to early clinical development and in identifying factors influencing risk for new investigational medicinal products (IMPs).

Read More+

PV Committee Vacancy

24th July 2017

The RQA Good Pharmacovigilance Practice Committee is recruiting a new committee member. We are open to applications from all parties, but may be particularly interested in those currently employed in a biotech organisation, or those with expertise with safety databases, perhaps working in the PV-IT world. Please contact Louise Handy, the Committee Chair, on louise@handyconsulting.co.uk or pharmacovigilance@therqa.com, providing details of your experience and what you would bring to the committee as an active member.

Read More+

New recruitment opportunity

12th July 2017

A new recruitment opportunity added to the website - QA Manager, Charles River, France

Read More+

Recruitment opportunity

12th July 2017

Another recruitment opportunity added to the website - Quality Assurance Manager (part time), UCL Cancer Institute, London

Read More+

Regulatory and procedural guidelines (human and veterinary)

12th July 2017

This guidance specifies the technical requirements and the process of transmission of individual case safety reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the European Economic Area.

Read More+

European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance

5th July 2017

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have. It provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to Applicants in preparing their request.

Read More+

First ever guidance for stem cell therapies in animals published

27th June 2017

Document gives advice on sterile manufacturing processes for veterinary stem cell medicines The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has approved today the first ever guidance at European Union (EU) level for stem cell-based medicines for veterinary use, in the form of a question-and-answer document prepared by the CVMP’s Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)

Read More+

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

21st June 2017

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.

Read More+

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

19th June 2017

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.

Read More+

Welcome to our new website

2nd June 2017

Welcome to our new website. We would appreciate any feedback you may have. Please send an e-mail to info@therqa.com with your comments.

Read More+