Widler & Schiemann AG support WHO on GCP Training
Two successful workshops conducted in the Philippines and Nigeria
Read
FDA Releases Guidance for Acceptance of clinical Data from trials outside the USA
New Guidance issued by FDA for sponsors of medical devices who want to use their clinical data from trials outside the US for an FDA submission
Read the pdf
Read
EMA on Gene Therapy
The European Medicines Agency invites feedback on their latest draft guidance
Read more online
Read
Master Protocols proposed by FDA
FDA’s Woodcock proposes master protocols, infrastructure to increase clinical trial efficiency, reduce costs
Read more online
Read
Beat Widler presents at Drug Development Expert Workshop in Frankfurt, Germany
Risk-based study management – dos and don’ts
Read the pdf
Read
WHO Workshop in Manila
Beat Widler conducts GCP Workshop on behalf of WHO in Manila
FDA Releases Guidance for Clinical Trial Sponsor-Investigators
New Guidance issued by FDA for investigators on how to file an IND (investigational new drug) application
Read the pdf
Read
Endpoint Adjudication Methods used in Clinical Trials for 69% of the NMEs approved by FDA and 41% by EMA
Beat Widler with Ken Getz from Tufts University and colleagues from our partners published a research article on DIA’s Therapeutic Innovation & Regulatory Science, Journal
Read
WHO Statement on Public Disclosure of Clinical Trial Results
Ethical imperative and timeframe definitions
Read more online
Read
Providing patients with outcomes of clinical trials
Initiatives to informing patients after their participation in a clinical trial of the outcome
Read more online
Read
Faster Clinical Trial results reporting
Using TrialScope Convert can help you speed up your clinical trial results – and it is free!
Read more online
Read
Clinical Trial Oversight Summit Boston
Peter Schiemann to speak at the Clinical Trial Oversight Summit, Boston, MA, June 1-3, 2015
Read more online
Read
FDA invites comments on their Guidance for Clinical Trial Sponsors:
Establishment and Operation of Clinical Trial Data Monitoring Committees
Read more online
Read
RbM Data reveals: Site screening Due Diligence improves patient dropout and retention
A way to utilize RbM for patient retention
Read more online
Read
Case Study: Using RbM to evaluate and predict site engagement
RbM can do more than just deploy monitors
Read more online
Read
FDA Draft Guidance on the use of electronic Informed Consent
A Q&A guide on the use of electronic Informed Consent in Clinical Investigations
Read the pdf
Read
Swiss Federal Office for Public Health launches new web site
The webpage has been completely revised and contains now also tools for researchers! These are the wizard to help categorise research projects, examples of trials and a glossary in four languages and more…
Visit the website
Sentiment Analysis: Understand your Healthcare Customers
Beat Widler co-authors article on Applied Clinical Trials
Read more online
Read
FDA - CTTI recommendations for GCP training
How frequently is GCP training needed and what should be included?
Read the pdf
Read
EMA updated their Q&A on GCP webpage
How should data be presented when they are sent to the inspection team prior to a GCP inspection requested by the CHMP?
Read more online
Read
Does the TransCelerate RbM Guidance Offer Standardization?
Beat Widler & Peter Schiemann quoted on Applied Clinical Trials Blog Post
Read more online
Read
New FDA Draft Guidance on Expanded Access:
Individual Patient Expanded Access Applications: Form FDA 3926
Read the pdf
Read
Applied Clinical Trials
RbM Guidance Document published on “Applied Clinical Trials”
Read it online
Read
And finally another FDA Final Guidance for Industry
Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act
Read the pdf
Read
Another FDA Final Guidance for Industry
Providing Regulatory Submissions In Electronic Format -Standardized Study Data
Read the pdf
Read
Season's Greetings!
The whole Widler & Schiemann Ltd. team wishes you happy holidays and a successful and prosperous new year 2015!
Read
FDAs Final Guidance for Industry
Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format
Read the pdf
Read
Exception From Informed Consent Requirements for Emergency Research
This is a 17 Nov 2014 update from the previous MAPP version dated 4 Feb 2003
Read the pdf
Read
Rare Pediatric Disease Priority Review Vouchers - Guidance for Industry
FDA has published its draft guidance on rare pediatric disease priority review.
Read the pdfRead more online
Read
European Guidelines on ePrescriptions
Guidelines on ePrescriptions were adopted by the European eHealth Network on 18th November 2014
Read more online
Read
New Data Dashboard Tool Shares FDA’s Inspection, Compliance and Recall Data
Inhalt: As part of FDAs commitment to transparency, FDA is pleased to announce that they have released a new online tool to provide insight into their compliance, inspection, and recall activities.
FDAs new dashboard
Read
Proposed changes to Directive 2001/20/EC
The European Commission, Parliament and Council published the proposal for repealing the Directive 2001/20/EC on "Clinical Trials on Medicinal products for Human Use". Download the document here:
Download as PDF
Risk-based Quality Management
EMA publishes final version of their Reflection Paper on Risk-based Quality Management in Clinical Trials
Download it here!
Clinical Quality Forum, Beijing, China
Beat presenting at the 1st International Forum on the Quality of Clinical Research, Beijing, 22 - 23 October 2013
Pictures on Flickr.com
Q&A on Design Space Verification
EMA and FDA publish new guidance on adhering to QbD principles:
Download the PDF
DIA Clinical Forum Dublin 2013
Peter Schiemann presented at the Clinical Forum in October 2013 about "A holistic Approach to Monitoring Clinical Trials". Download presentation here:
Download the Presentation
Pharma Compliance Europe 2013
Wolfgang Beck was invited to speak at Pharma Compliance Europe 2013 about 'Service Honoraria at Fair Market Value'.
View the slides (pdf)
"A Roadmap For Sharing Clinical Trial Data"
Widler & Schiemann AG invited to participate and represent ABPI at the EFPIA/PhRMA event on "A Roadmap For Sharing Clinical Trial Data"!
Conference Report Conference Website
EFGCP, ACRES, EORTC and UCL organize a hands-on workshop
EFGCP, ACRES, EORTC and UCL organize a hands-on workshop on how to implement a risk based approach to managing quality in clinical trials
Download the pdf
Swiss government approved the new ordinance regarding the Swiss clinical research law
Beat Widler was invited by the Federal Office of Public Health (BAG) to provide a critical assessment of the new ordinance. Read the article here (german):
Publication
Article about Quality Risk Management in RAPS Journal
WSQMS publish Article about Quality Risk Management in RAPS (Regulatory Affairs Professionals Society) Journal. Download article here:
Download as PDF
Article in EFGCP news by Beat Widler
You can find all new information from EFGCP and an article by Beat Widler in their summer report which you can find at
their website or in this pdf for download:
Download as PDF
New Website
We are glad to welcome you on our new website, designed and implemented by 3K-Webdesign
Read
Evaluation Results of our Webinar
Our recent webinar was a success. We are very proud to present the positive feedback of our clients. Click the button below to download the Evaluation.
Download the pdf
