Regulatory Archives - Insights From Our Labs to Yours

Overcoming challenges in the processes of characterization, assessment, and registration of your UVCB in Europe

by Labcorp Drug Developmentupdated on Thursday, June 3, 2021Monday, March 8, 2021

The demand under European regulations for detailed environmental risk assessment of UCVBs is challenging both the industry and regulators alike. Read on to explore the challenges and possible ways of overcoming them.

Implications of the changes in the EU General Food Law (Transparency Regulation)

by Labcorp Drug Developmentupdated on Tuesday, June 8, 2021Thursday, January 7, 2021

The revised EU GFL (Reg (EC) 2019/1381), or transparency regulation, comes into force on 27 March 2021 and sees changes in the notification of studies, submission of dossiers via IUCLID and the publication of all study reports, to name a few. Read on to find out how these changes may …

How to answer basic physical chemical questions for your chemical and agrochemical substances when test guidance changes and as regulatory standards evolve

by Labcorp Drug Developmentupdated on Monday, October 19, 2020Monday, October 19, 2020

Although most physiochemical endpoints are standard for crop and chemical active substances, selection of the right test method to assess them is critical. This blog reviews some standard endpoints and looks at the tests used, in the light of changing regulatory expectations and revised test methodologies for difficult substances.

Overcoming the unique drug safety and regulatory challenges faced by small and medium biopharma

by Labcorp Drug Developmentupdated on Monday, June 7, 2021Wednesday, July 29, 2020

Leveraging an Integrated, Holistic Solution Small- and medium-sized enterprises typically do not have the resources and expertise to establish an internal pharmacovigilance (PV) operation, as this would divert valuable time and money from product development. As a result, clinical development or regulatory groups, which are not specialized in PV, often …

Pharmacovigilance: a focus on EU drug safety excellence

by Prashant Joshi, Senior Director, Patient Safety Solutions, Covanceupdated on Monday, June 7, 2021Wednesday, July 22, 2020

A compelling model for small and medium-sized organizations in the current EU regulatory landscape Regulatory dynamics in the EU continue to evolve, with higher expectations for pharmacovigilance (PV) as each nation has rigorous and complex patient safety regulations. The shifting landscape represents a unique challenge for small- and medium-sized enterprises …

EU MDR and IVDR implementation and deadlines – Proposal for EU MDR application delay

by Liliana Omar, Regulatory and Quality Project Directorupdated on Tuesday, May 26, 2020Thursday, May 28, 2020

The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on 25 May 2017 replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD). As indicated in the regulations, from the date the regulations entered into force, …

GDPR: What is it and what does it mean for your clinical studies: Part II

by Mary Kay Kessinger Sobcinski, RN, BSN, MHA, Senior Clinical Principal Advisorupdated on Monday, June 7, 2021Tuesday, May 26, 2020

This two-part blog serves to summarize our Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by Medical Device and Diagnostic Solutions through a review of the GDPR …

GDPR: What is it and what does it mean for your clinical studies: Part I

by Mary Kay Kessinger Sobcinski, RN, BSN, MHA, Senior Clinical Principal Advisorupdated on Monday, June 7, 2021Tuesday, May 26, 2020

This two-part blog serves to summarize the Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by our Medical Device and Diagnostic Solutions through a review of the …

The simple steps to successful active substance renewal

by Labcorp Drug Developmentupdated on Monday, June 7, 2021Wednesday, May 20, 2020

The renewal process in the EU and the US for existing active substances requires advance planning and careful and attentive management. Following is practical advice to help you tackle the renewal of your plant protection active substance. 1. Form a Taskforce or Consortium A major difference between the application for …

Are your CERs ready for MDR?

by Meghan Swanson, Regulatory/Quality Project Managerupdated on Monday, June 7, 2021Wednesday, May 6, 2020

Do you understand the key changes for CERs? The interplay of MDR and MEDDEV is complex. The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of clinical evaluation. Now, even with the all but official postponement of …