WSQMS Homepage


May 2, 2018

Beat Widler to moderate session at EFGCP Workshop 18th June 2018, London
Investigators meet Inspectors workshop by EFGCP in the light of ICH E6R2

Investigators have to comply with GCP guidance and regulation while integrating clinical trial activities into their routine care environment. This is an increasing challenge, and inspectors often see only the compliance aspects of this integration. The interpretation and application of guidance and regulation are not always clear to investigators.

EFGCP will provide participants with an opportunity to directly ask inspectors all the questions they always wanted to ask. And inspectors will have an opportunity to understand more about the constraints and motivations of investigators performing clinical trials in their clinical settings.

Read more online

USFDA issue new draft Guidance on inclusion of pregnant women in clinical trials
Comments and suggestions regarding this draft document should be submitted within 60 days of publication

This guidance provides recommendations about how and when to include pregnant women in drug development clinical trials for drugs and therapeutic biological products based on the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this subject. Specifically, this guidance supports an informed and balanced approach to gathering data on the use of drugs and biological products during pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk. This draft guidance is intended to serve as a focus for continued discussions among various entities such as the Agency, pharmaceutical manufacturers, the academic community, institutional review boards (IRBs), and others who are involved with the conduct of clinical trials in pregnant women.

This guidance discusses the scientific and ethical issues that should be addressed when considering the inclusion of pregnant women in drug development clinical trials. From a scientific and ethical standpoint, the population of pregnant women is complex based on the interdependency of maternal and fetal well-being, and the need to take into consideration the risks and benefits of drug therapy to both woman and fetus (American College of Obstetricians and Gynecologists 2015). The scientific and ethical issues discussed in this guidance apply both to clinical trials that enroll pregnant subjects and to clinical trials that allow enrolled subjects who become pregnant to remain in the trial.

Read the pdf

New USFDA draft Guidance on in-vitro Diagnostics in Oncology Trials
Comments and suggestions regarding this draft document should be submitted within 60 days of publication

The purpose of this guidance is to describe an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk (SR), non-significant risk (NSR), or exempt. If found to be SR, such a trial may require approval of an investigational device exemption (IDE) in addition to an investigational new drug application (IND). FDA encourages sponsors to use the streamlined process described in this guidance when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory review.

Regardless of whether a study involving an investigational IVD is determined to be SR or NSR, it must follow the abbreviated requirements outlined in 21 CFR 812.2(b),3 including generating and retaining data that demonstrate analytical validation of the investigational IVD. Sponsors can contact CDRH directly with questions relating to analytical validation of the investigational IVD.

Read the pdf

USFDA’s Revision 1 of the Special Protocol Assessment Guidance
In Effect: April 2018 – May 2020

This guidance provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies (i.e., a Request for SPA (hereafter Request); see section III., Eligible Protocols and General Information) to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. An SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses) for a study intended to support a future marketing application. These elements are critical to ensuring that the trial conducted under the protocol can be considered an adequate and well-controlled study that can support marketing approval. Feedback on these issues provides the greatest benefit to sponsors in planning late-phase development strategy. However, an SPA agreement does not indicate FDA concurrence on every protocol detail, as described further in section III.B.2, Reaching SPA Agreement With FDA. The existence of an SPA agreement does not guarantee that FDA will file (accept) a new drug application (NDA) or biologics license application (BLA), or that the trial results will be adequate to support approval. Those issues are addressed during the review of a submitted application and are determined based on the adequacy of the overall submission.

Read the pdf

Increasing oversight of API manufacturing through international collaboration
Report on the International API inspection program published

The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as highlighted in the International API inspection programme report for 2011-2016, published on 12th April.

Read more online

New EMA Draft Guideline on Clinical Evaluation of Vaccines
Comments can be sent in until 30th October 2018

This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases. It includes considerations for trials intended to document the safety, immunogenicity and efficacy of new candidate vaccines and to support changes in the prescribing information of licensed vaccines. It also considers the need for and use of vaccine effectiveness studies.

Read the pdf


You receive this newsletter, because you have subscribed to it.
If you no longer want to receive this newsletter, you can easily leave the list at this Website.You can't view the images in this e-mail? Click here to open it in your browser.

Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - -