Navigate Compliance Waters

Widler & Schiemann AG can provide you with innovative, creative and cost effective answers to your questions and needs in the areas of Clinical Quality Management. With our vast experience and extensive network in the industry and the regulators we are uniquely positioned to identify and provide the best solutions for you.

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  • 25 May 2017
  • 1
CFDA prunes medical device standards management guidelines
CFDA amends Medical Device Guideline
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  • 18 May 2017
  • 16
Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials
FDA’s CDER and C-Path’s PRO consortium second workshop
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  • 10 May 2017
  • 45
Summary of changes to the guidance of publication of clinical trial data by EMA
Update to the guidance published on March 03, 2016
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  • 05 May 2017
  • 55
The EFPIA Disclosure Experience: An Update
EFPIA offers an update on media and industry responses
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  • 30 April 2017
  • 63
EMA publishes new draft GCP guideline on TMF requirements
The deadline for comments is 11 July 2017
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  • 20 April 2017
  • 73
Small and Mid size Biotech Companies’ EDMS
Pocket EDMS URS include now TMF requirements
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  • 15 April 2017
  • 103
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs Release: 15.04.2017 02:03:36
Medicines where suitable alternative data are available can remain on market
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  • 10 April 2017
  • 104
China FDA publishes first report on self-inspection rule
Inspection Report for Drug Clinical Trial Data
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  • 05 April 2017
  • 108
New and revised FDA guidances for 2017
CDER’s plan for guidances for 2017
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  • 03 April 2017
  • 123
FDA and EMA to collaborate closer on GMP Inspections
Update to the 1998 agreed mutual recognition agreement
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  • 20 March 2017
  • 158
CFDA sets out principles for generic equivalency clinical trials
Follow up to last years’ release of new Bioequivalence guidelines
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  • 16 March 2017
  • 158
FDA publishes OSI Statistics
OSI (Office of Scientific Investigations) publishes an overview of metrics on their homepage
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  • 12 March 2017
  • 192
Over 1,000 studies now recorded in EU register of post-authorisation studies
EU PAS Register increases transparency of research in medicines after they have been authorised in the EU
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  • 08 March 2017
  • 232
EMA invites comment on revised “Document Access Policy”
Comments from stakeholders invited until 18 May 2017
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  • 04 March 2017
  • 248
ICH invites comments on Efficacy Guidelines
ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6
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  • 01 March 2017
  • 176
US Government publishes revision for the protection of human subjects
Widler & Schiemann’s interpretation of the new policy
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  • 18 November 2016
  • 53
Global GCP Guideline Amendment Adopted!
This amendment will now be implemented by ICH members through national and regional guidance
Read the ICH Press Release
  • 30 September 2016
  • 542
Chinese Manufacturers struggle with Quality
While Chinese companies export about 50% of global APIs they struggle with international quality requirements
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  • 20 September 2016
  • 478
Transparency in drug regulation
Publication of assessment reports in Europe and Australia makes information on medicines more easily available
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  • 16 September 2016
  • 462
EU collaboration strengthens safety monitoring of medicines
European Commission publishes three-year report on implementation of pharmacovigilance legislation
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  • 08 September 2016
  • 510
Better monitoring of biological medicines
New chapter in guidelines on good pharmacovigilance practices
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  • 04 September 2016
  • 567
CFDA sets out punishments for counterfeit clinical trial data
Chinese authorities try to go against this trend by enforcing new legislations of punishment and fines
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  • 20 August 2016
  • 591
FDA issues draft guidance on drug development in rare diseases
This draft guidance is open for comments for the next 60 days.
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  • 15 August 2016
  • 641
EMA publishes Pharmacovigilance Report
Annual report of pharmacovigilance inspectors’ working party for 2014
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  • 10 August 2016
  • 638
Audits in GCP and Beyond
The third issue of GCP auditing will be released soon
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  • 05 August 2016
  • 698
UK TAKES AIM AT PHARMA PERKS
Sunshine rule announced in the UK
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  • 31 July 2016
  • 564
CFDA issues extensive DRR draft amendments
The China FDA invites comments on their latest revision of their Drug Registration Regulation
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  • 31 July 2016
  • 641
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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  • 31 July 2016
  • 564
EMA to introduce Public Hearings
Vox Populi at EMA’s PRAC
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  • 31 July 2016
  • 582
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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  • 21 March 2016
  • 727
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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  • 14 March 2016
  • 940
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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  • 07 March 2016
  • 965
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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  • 03 March 2016
  • 1063
Oliver Hellstern, MD joins Widler & Schiemann
Oliver Hellstern, Expert in Drug Safety, joins Widler & Schiemann Ltd. on March 1st, 2016
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  • 22 February 2016
  • 1114
Stronger data protection rules for Europe
The EU adopts the data protection reform package
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  • 15 February 2016
  • 1002
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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  • 10 February 2016
  • 960
Germany: New Anti-Corruption Law
Fighting Private Sector Bribery and Cross-Border Corruption
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  • 09 February 2016
  • 1015
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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  • 09 February 2016
  • 990
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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  • 21 January 2016
  • 889
Endpoint Adjudication Survey Results are in!
The recently launched endpoint adjudication survey results are out:
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  • 14 January 2016
  • 980
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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  • 07 January 2016
  • 872
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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  • 06 January 2016
  • 932
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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  • 20 December 2015
  • 1145
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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  • 15 December 2015
  • 948
ACRES and Ethical GmbH, Switzerland to collaborate on eAdjudication
ACRES integrates eAdjudication into shared global platform of integrated technologies
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  • 10 December 2015
  • 1196
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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  • 05 December 2015
  • 951
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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  • 02 December 2015
  • 996
MHRA wants to see paper records retained
MHRA commented in their discussion forum on retention of trial records
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  • 21 November 2015
  • 1021
Survey on endpoint adjudication launched!
Mimmo Garibbo, Dirctor at Ethical GmbH launches survey on endpoint adjudication
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  • 17 November 2015
  • 226
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
  • 14 November 2015
  • 822
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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  • 07 November 2015
  • 990
ICH goes Risk-based!
Beat Widler co-authors article in Applied Clinical Trials (ACT)
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  • 02 November 2015
  • 963
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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  • 01 October 2015
  • 1518
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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  • 01 October 2015
  • 1084
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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  • 01 October 2015
  • 1031
Cheaper Generics for poor Countries
European Commission backs bypassing drug patents for poor nations
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  • 31 August 2015
  • 1704
DIA Global Forum Online August
Contribution on Quality Matters by Beat Widler & Peter Schiemann
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  • 20 August 2015
  • 1351
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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  • 15 August 2015
  • 1009
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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  • 10 August 2015
  • 1329
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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  • 05 August 2015
  • 1026
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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  • 31 July 2015
  • 276
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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  • 31 July 2015
  • 1309
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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  • 21 July 2015
  • 1611
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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  • 14 July 2015
  • 1131
FDA’s page on Expanded Access Programs
FDA’s current policies on compassionate use can be found on this homepage
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  • 08 July 2015
  • 224
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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  • 07 July 2015
  • 1257
Widler & Schiemann AG support WHO on GCP Training
Two successful workshops conducted in the Philippines and Nigeria
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  • 02 July 2015
  • 1510
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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  • 20 June 2015
  • 1515
EMA on Gene Therapy
The European Medicines Agency invites feedback on their latest draft guidance
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  • 15 June 2015
  • 1173
Master Protocols proposed by FDA
FDA’s Woodcock proposes master protocols, infrastructure to increase clinical trial efficiency, reduce costs
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  • 10 June 2015
  • 1514
Beat Widler presents at Drug Development Expert Workshop in Frankfurt, Germany
Risk-based study management – dos and don’ts
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  • 05 June 2015
  • 280
WHO Workshop in Manila
Beat Widler conducts GCP Workshop on behalf of WHO in Manila
  • 05 June 2015
  • 1229
New FDA BIMO Slides are out!
The new Bioresearch Monitoring Metrics for 2014
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  • 01 June 2015
  • 1410
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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  • 20 May 2015
  • 1166
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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  • 12 May 2015
  • 1096
WHO Statement on Public Disclosure of Clinical Trial Results
Ethical imperative and timeframe definitions
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  • 08 May 2015
  • 1377
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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  • 04 May 2015
  • 1472
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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  • 03 May 2015
  • 1388
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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  • 30 April 2015
  • 1331
REMS Update
Modifications and Revisions on the FDA Guidance
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  • 20 April 2015
  • 1250
FDA invites comments on their Guidance for Clinical Trial Sponsors:
Establishment and Operation of Clinical Trial Data Monitoring Committees
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  • 15 April 2015
  • 1535
RbM Data reveals: Site screening Due Diligence improves patient dropout and retention
A way to utilize RbM for patient retention
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  • 10 April 2015
  • 1289
Case Study: Using RbM to evaluate and predict site engagement
RbM can do more than just deploy monitors
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  • 05 April 2015
  • 1410
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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  • 31 March 2015
  • 324
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
  • 31 March 2015
  • 1498
Sentiment Analysis: Understand your Healthcare Customers
Beat Widler co-authors article on Applied Clinical Trials
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  • 21 March 2015
  • 1238
FDA - CTTI recommendations for GCP training
How frequently is GCP training needed and what should be included?
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  • 14 March 2015
  • 1245
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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  • 07 March 2015
  • 1318
Does the TransCelerate RbM Guidance Offer Standardization?
Beat Widler & Peter Schiemann quoted on Applied Clinical Trials Blog Post
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  • 26 February 2015
  • 1178
New FDA Draft Guidance on Expanded Access:
Individual Patient Expanded Access Applications: Form FDA 3926
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  • 23 January 2015
  • 281
RbM Guidance Document: Ten Burning Questions about Risk-Based Study Management
You can read this document and others in our Resources/Publications section. Read the pdf Visit the publications section
  • 14 January 2015
  • 1264
Applied Clinical Trials
RbM Guidance Document published on “Applied Clinical Trials”
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  • 10 January 2015
  • 1242
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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  • 01 January 2015
  • 1278
Another FDA Final Guidance for Industry
Providing Regulatory Submissions In Electronic Format -Standardized Study Data
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  • 24 December 2014
  • 1337
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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  • 22 December 2014
  • 1382
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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  • 18 December 2014
  • 1881
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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  • 09 December 2014
  • 1749
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
  • 03 December 2014
  • 1317
European Guidelines on ePrescriptions
Guidelines on ePrescriptions were adopted by the European eHealth Network on 18th November 2014
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  • 14 November 2014
  • 1585
FDA GCP Training
The FDA conducts GCP training on site, but also provides on-line training and a whole training program
FDA Clinical Investigator Training CourseFDA's Clinical Investigator Training Course Read
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Quality by Design

Our extensive track record and our close collaboration with regulators positions us uniquely to support clients in QbD projects with the latest development in methodologies and regulations.

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Quality Risk Management

As recognized experts in QRM we provide leading edge knowledge and support to clients developing and implementing a QRM approach.

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Risk-based Monitoring & Study Management

With the QbD and QRM methodologies we are in a unique position to help you design your new approach to a targeted and centralized monitoring and study management approach.

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SOP Management and Re-engineering

We have developed and successfully deployed a new approach to SOP management. Structured Content Management (SCM) allows tailoring the content of an SOP to the exact needs of each user group. With this we have created a whole set of clinical development SOPs that can easily be deployed in your company.

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Quality Strategy, Quality Policy & Quality Manuals

Many years of experience with large and small organizations developing Quality Strategies and key Quality documentation such as Quality Policy and Manual tailored to the customers specific needs.

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Design & Implementation of a Quality Management System

We have worked with large and small organizations and helped them develop and deploy a fit-for-purpose QMS. Their experience has allowed them to detect early obstacles or even resistance and to propose the right change management steps.

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GCP, Quality Risk Management & Quality Methodology Training

We are proud to be able to offer you tailored training courses as an in-house training for your staff either as refresher training or for newcomers.

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Service Provider & Vendor Qualification and Assessment

We have extensive experience in qualifying vendors and designing processes ranging from pre-contract assessments (risk based) to in process audits and quality risk assessments.

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GCP Issue Management

We have combined more than 35 years of experience in the GCP field and are viewed by many of our peers in the industry as thought-leaders in compliance matters and issues.

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Independent QA Support & Services

We have a demonstrated track record of successful implementations of QA plans and strategies as well as CAPA (Corrective and Preventive Action) programs and QA infrastructure and organizations.

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Inspection Readiness Support

We have developed and implemented processes to make organizations inspection ready. A toolkit has been developed to assist teams and functions to reach an inspection ready state.

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Quality Management of Pharmacovigilance Processes

We have developed a systematic approach to ensuring a continuous oversight on safety reporting whether in clinical trials or of spontaneous cases from marketed products. This methodology is based on the QbD and QRM principle and can be tailored to the customers' need.

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Corporate Compliance

With our experience we are best positioned to define the systems’ requirements, perform a risk analysis and define and rollout of processes for health care compliance.

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Regulatory Intelligence Clinical Quality & Risk Management

Through our network, we are uniquely placed to learn early of planned changes that may impact your operations and even more important we are able to put these in the right legal and regulatory context to guide you to make the right process and organizational changes or to confidently refuse any change.

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