Last weeks round-up; 4 – 8 November 2019

THE MHRA GDP & GMP SYMPOSIUM

We’re proud to have our Real Expert, Niamh Miller, on site at the MHRA GMP & GDP Symposium in London next week to discuss the latest updates on guidance and increasing complexity in the manufacturing and distribution chain requirements with our industry peers. If you’re also attending, get in touch! Niamh would love to see you there! Contact us to arrange a meeting: https://lnkd.in/daQjxxj

AMERICAN COLLEGE OF TOXICOLOGY 40TH ANNUAL MEETING

Will you be at the American College of Toxicology 40th Annual Meeting 17-20 November 2019 in Phoenix, Arizona? Our Real expert, Leslie Dowling, will be giving the EU presentation in the Continuing Education session CE08: Regulatory Meeting Preparation and Conduct: US, EU, and China on 17 November, with Q&A at the panel discussion at the end of the session. For more info or to arrange a one-on-one, email ldowling@realregulatory.com

NEW REAL REPORT: GOOD CLINICAL PRACTICE FOR CLINICAL TRIALS

Good Clinical Practice (GCP) is an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. All clinical trials must comply with GCP regulations with compliance assessed via audit by a regulatory body. MHRA is a regulatory body with vast experience in conducting GCP audits and has documented that knowledge and experience in MHRA guidance document ‘GCP for clinical trials’ and GCP Inspection Metrics Report. Real Regulatory article ‘Good Clinical Practice for Clinical Trials’ provides a succinct summary of the MHRA intelligence addressing assessment of GCP compliance via the MHRA GCP inspection process, MHRA GCP inspection findings for 99 GCP audits conducted between April 2016 and March 2017 and available GCP compliance tools to help relevant parties comply with GCP regulations. If you are involved in any aspect of clinical trials, then this article is of interest to you and can be found on the RRL website. https://lnkd.in/dEDcnk3

EUROPEAN COMMISSION APPOINTS SECOND NOTIFIED BODY TO THE IN VITRO DIAGNOSTICS REGULATION

The EC has designated a 2nd IVDR Notified Body (NB), namely BSI Assurance UK Ltd (BSI) https://bit.ly/36xrAMu. German NB DEKRA Certification GmbH was the first NB to be designated (Oct 10th). BSI is the first notified body to achieve full scope designation, which covers all devices specified under the Implementing Regulation (EU) 2017/2185. Both NB ‘s are listed in the EC NANDO database linked here https://bit.ly/2qucB5m. It’s probably a good idea to regularly check this link for further designations to both the Medical Device Regulation (MDR) and IVDR. It is a constantly evolving list.

ANTIMICROBIAL RESISTANCE : FEEDBACK FROM 4TH TRIPARTITE MEETING BETWEEN EMA, FDA & PDMA

In late September, EMA,FDA and PDMA further discussed alignment on clinical trial designs for key indications for antibacterial drugs. Notably, they also expanded the discussions to include antifungal agents, an area which is also affected by growing antimicrobial resistance and where clinical development programs can be challenging. Further information can be found under the link below; https://lnkd.in/dPDnAJF