EMA publishes Pharmacovigilance Report
Annual report of pharmacovigilance inspectors’ working party for 2014
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UK TAKES AIM AT PHARMA PERKS
Sunshine rule announced in the UK
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CFDA issues extensive DRR draft amendments
The China FDA invites comments on their latest revision of their Drug Registration Regulation
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European Commission launches EU-U.S. Privacy Shield
A new framework for stronger protection for transatlantic data flow to build trust
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EMA plans to revise guidance on first-in-human clinical trials
Comments invited on a concept paper on changes intended to support best practices
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Draft Guidance on format of the Risk Management Plan (RMP) in the EU – in integrated format
The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers.
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EMA publishes two Drug Safety related Draft Guidance for Consultation
Guideline on Good Pharmacovigilance Practices (GVP) 3 - Module V – Risk management systems (Rev 2)
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FDA issues new Guidance on Safety Data in late Stage Trials
Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations
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Oliver Hellstern, MD joins Widler & Schiemann
Oliver Hellstern, Expert in Drug Safety, joins Widler & Schiemann Ltd. on March 1st, 2016
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Stronger data protection rules for Europe
The EU adopts the data protection reform package
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EMA launches new IT System
On 1 February 2016, the Agency is launching a new IT system to answer stakeholders’ IT-related queries and services.
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Germany: New Anti-Corruption Law
Fighting Private Sector Bribery and Cross-Border Corruption
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EMA delays enforcement of new Clinical Trial Regulation
EMA will not enforce the new Clinical Trial Regulation as planned in May 2016 – 2017 is more likely
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New FDA Draft Guidance on Safety Assessment for IND Safety Reporting
The new Draft Guidance on Safety Assessment for IND Safety Reporting is open for comments to be sent to FDA
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Endpoint Adjudication Survey Results are in!
The recently launched endpoint adjudication survey results are out:
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EMA aims to reinforce compliance with good clinical practice
Regulatory information - Replacement of GCP non-compliant pivotal studies in centralised marketing-authorisation applications not accepted
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New FDA Guidance on meetings with Biosimilar Companies
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants: Guidance for Industry
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FDA issues new Draft Guidance on Communication between Sponsors and FDA
Best Practices for Communication Between IND Sponsors and FDA During Drug Development-Guidance for Industry and Review Staff
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Beat Widler to present at the 2nd Academic Symposium
Beat Widler is invited to speak on the Clinical Research Quality & China New Drug 50 Roundtable Forum in Beijing, China
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ACRES and Ethical GmbH, Switzerland to collaborate on eAdjudication
ACRES integrates eAdjudication into shared global platform of integrated technologies
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Widler & Schiemann to represent ACRES at EMA Inspectors Working Group
Peter Schiemann represented ACRES, the Alliance for Clinical Research Excellence and Safety at the EMA IWG Meeting on EDC systems and risk based monitoring in Clinical Trials
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ICH announces organizational changes!
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly and Management Committee on 23 October 2015
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MHRA wants to see paper records retained
MHRA commented in their discussion forum on retention of trial records
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Survey on endpoint adjudication launched!
Mimmo Garibbo, Dirctor at Ethical GmbH launches survey on endpoint adjudication
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2nd Academic Symposium on the Clinical Research Quality & China New Drug 50 Roundtable Forum in Beijing
Beat Widler will speak at the conference about "Development and Management New Trends of Global Clinical Research" on December 4th 2015
Beat Widler co-authors article on adjudication methods
An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals
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ICH goes Risk-based!
Beat Widler co-authors article in Applied Clinical Trials (ACT)
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CluePoints and Widler & Schiemann announce Partnership
CluePoints and WSQMS signed a partnership agreement to support each other in projects with clients
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Free Webinar on Implications of ICH E6 Amendment
In a webinar on October 20th, 2015, Clinerion and Widler & Schiemann will explain the implications of the ICH E6 Amendment on Managing Clinical Trials
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Workshop on Risk-based Monitoring
Artem Andrianov and Peter Schiemann to lead workshop at PCT Conference in November in Hamburg, Germany
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Cheaper Generics for poor Countries
European Commission backs bypassing drug patents for poor nations
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DIA Global Forum Online August
Contribution on Quality Matters by Beat Widler & Peter Schiemann
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EMA Draft Guideline on the Scientific Application and the practical Arrangements necessary to implement Regulation (EC) No 507/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use falling within the Scope of Regulation (EC)
This draft guideline has been updated in order to reflect the experiences accumulated with conditional marketing authorisations and is therefore released for repeated public consultation.
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EMA Draft Guideline on the Scientific Application and the practical Arrangements necessary to implement the Procedure for accelerated Assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004
EMA provides further clarification on the accelerated assessment procedure
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Beat Widler authors article on Inspection Readiness
The German Society for Pharmaceutical Medicine published an article by Beat Widler on Inspection Readiness (in German)
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FDA Draft Guidance on Metrics in Manufacturing
FDA released its draft guidance on metrics for manufacturing for comments within the next 60 days
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E6 (R2) Addendum posted by ICH
This Integrated Addendum to ICH E6(R1) is proposed to modernise the ICH E6 Guideline by supplementing with additional recommendations which will facilitate broad and consistent international implementation of new methodologies.
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EMA to encourage use of Scientific Advice for Post-Authorisation Safety Studies
12-month pilot will support design of high-quality safety studies!
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FDA on early trials in Cellular and Gene Therapy Products
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
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FDA’s page on Expanded Access Programs
FDA’s current policies on compassionate use can be found on this homepage
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Embracing RBM, a company’s smaller size can become an advantage
RBM as Competitive Advantage for Mid-sized CROs (White Paper by A. Andrianov)
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Widler & Schiemann AG support WHO on GCP Training
Two successful workshops conducted in the Philippines and Nigeria
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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
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EMA on Gene Therapy
The European Medicines Agency invites feedback on their latest draft guidance
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Master Protocols proposed by FDA
FDA’s Woodcock proposes master protocols, infrastructure to increase clinical trial efficiency, reduce costs
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Beat Widler presents at Drug Development Expert Workshop in Frankfurt, Germany
Risk-based study management – dos and don’ts
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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
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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
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WHO Statement on Public Disclosure of Clinical Trial Results
Ethical imperative and timeframe definitions
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Providing patients with outcomes of clinical trials
Initiatives to informing patients after their participation in a clinical trial of the outcome
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Faster Clinical Trial results reporting
Using TrialScope Convert can help you speed up your clinical trial results – and it is free!
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Clinical Trial Oversight Summit Boston
Peter Schiemann to speak at the Clinical Trial Oversight Summit, Boston, MA, June 1-3, 2015
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FDA invites comments on their Guidance for Clinical Trial Sponsors:
Establishment and Operation of Clinical Trial Data Monitoring Committees
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RbM Data reveals: Site screening Due Diligence improves patient dropout and retention
A way to utilize RbM for patient retention
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Case Study: Using RbM to evaluate and predict site engagement
RbM can do more than just deploy monitors
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FDA Draft Guidance on the use of electronic Informed Consent
A Q&A guide on the use of electronic Informed Consent in Clinical Investigations
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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…
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Sentiment Analysis: Understand your Healthcare Customers
Beat Widler co-authors article on Applied Clinical Trials
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FDA - CTTI recommendations for GCP training
How frequently is GCP training needed and what should be included?
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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?
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Does the TransCelerate RbM Guidance Offer Standardization?
Beat Widler & Peter Schiemann quoted on Applied Clinical Trials Blog Post
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New FDA Draft Guidance on Expanded Access:
Individual Patient Expanded Access Applications: Form FDA 3926
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Applied Clinical Trials
RbM Guidance Document published on “Applied Clinical Trials”
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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
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Another FDA Final Guidance for Industry
Providing Regulatory Submissions In Electronic Format -Standardized Study Data
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Season's Greetings!
The whole Widler & Schiemann Ltd. team wishes you happy holidays and a successful and prosperous new year 2015!
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FDAs Final Guidance for Industry
Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format
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Exception From Informed Consent Requirements for Emergency Research
This is a 17 Nov 2014 update from the previous MAPP version dated 4 Feb 2003
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Rare Pediatric Disease Priority Review Vouchers - Guidance for Industry
FDA has published its draft guidance on rare pediatric disease priority review.
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European Guidelines on ePrescriptions
Guidelines on ePrescriptions were adopted by the European eHealth Network on 18th November 2014
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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
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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:
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Risk-based Quality Management
EMA publishes final version of their Reflection Paper on Risk-based Quality Management in Clinical Trials
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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:
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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:
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Pharma Compliance Europe 2013
Wolfgang Beck was invited to speak at Pharma Compliance Europe 2013 about 'Service Honoraria at Fair Market Value'.
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"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
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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:
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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:
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New Website
We are glad to welcome you on our new website, designed and implemented by 3K-Webdesign
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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.
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