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.

Servicehandout:

Download as PDF
  • 18 October 2017
  • 6
China FDA to issue catalogue of all drugs marketed in China
A Chinese Version of the USFDA’s “Orange Book” will be available soon
Read
  • 14 October 2017
  • 20
Patient safety: Commission adopts acts on Good Manufacturing Practices for medicines
Focus on Marketed Products and Investigational Medicinal Products
Read more online Read
  • 08 October 2017
  • 40
USFDA is advancing the Goals of the Orphan Drug Act
An Update from the USFDA Commissioner on the achievements to date
Read more online Read
  • 04 October 2017
  • 37
Final USFDA Guidance on Real World Evidence and Medical Devices
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Read the pdf Read
  • 30 September 2017
  • 36
New USFDA Draft Guidance on submitting REMS in SPL Format
Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling Guidance for Industry
Read
  • 16 September 2017
  • 66
The new 2017 Good Clinical Practice Q&A Guide is available!
Dr. Beat Widler is a reappearing author for this guide and member of the editorial board
Read more online Read
  • 12 September 2017
  • 84
EMA Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: pediatric population
New Guideline open for comments until 13th October 2017
Read the pdf Read
  • 08 September 2017
  • 88
EMA prepares for Brexit
Business continuity plan aims to preserve Agency’s ability to protect public and animal health
Read more online Read
  • 04 September 2017
  • 98
SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION
RISK PROPORTIONATE APPROACHES IN CLINICAL TRIALS
Read the pdf Read
  • 01 September 2017
  • 114
Dr. Oliver Hellstern invited as lecturer for Pharmacovigilance at ETH Zurich
Our PV Practice Leader, Dr. Oliver Hellstern, to teach about Pharmacovigilance at the University ETH Zurich
Read more online Read
  • 01 September 2017
  • 107
Strengthening EU-US cooperation in medicine inspections
New commitment allows FDA to share full inspection reports with European Commission and EMA
Read more online Read
  • 20 August 2017
  • 109
New ICH E19 Guideline in development on Optimisation of Safety Data Collection
Guidance on targeted approach to safety data collection
Read the pdf Read
  • 16 August 2017
  • 141
EMA: Revised Guideline for Entry into Human
Guidance outlines strategies to identify and mitigate risks for trial participants
Read more online Read
  • 08 August 2017
  • 129
USFDA aims to foster generic drugs
A recent email announcement by USFDA lists the details
Read
  • 04 August 2017
  • 148
Update of the BIMO Guidance Manual
USFDA announced that a major revision BIMO manual was issued in April 2017 – Guidance for FDA staff
Read
  • 31 July 2017
  • 177
New USFDA Draft Guideline on Electronic Records and Signatures
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 - Questions and Answers
Read the pdf Read
  • 22 July 2017
  • 193
FDA Updates Part 11 Guidance for Clinical Trials to Include Mobile and Wearable Tech
Public Comments are invited until late August 2017
Read more online Read
  • 18 July 2017
  • 150
Brookwood Academy launches “PV Training for All” Module
EFGCP GCP Discussion Group reviewed the first module
Read more online Read
  • 15 July 2017
  • 190
New action plan to support SMEs as drivers of pharmaceutical innovation
16 actions identified for implementation in 2017-2020
Read more online Read
  • 12 July 2017
  • 119
EMA and EUnetHTA step up interaction to align data requirements
A new joint platform for parallel consultation will provide advice to medicine developers and facilitate access to medicines for patients
Read more online Read
  • 08 July 2017
  • 182
UK’s withdrawal from the EU
EMA publishes first thoughts on implications and mitigating actions.
Read more online Read
  • 04 July 2017
  • 177
China announced official ICH member
At the ICH Meeting in Montreal, China’s ICH membership was confirmed
Read the pdf Read
  • 01 July 2017
  • 136
Canada sets date for implementation of ICH E6 R2
The date shall be the 1st April 2018
Read more online Read
  • 20 June 2017
  • 196
East African Community looks to EMA as model for future regional agency
EMA and East African regulators met on 18-19 May 2017
Read more online Read
  • 16 June 2017
  • 190
Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions
Management Board endorsement starts countdown for stakeholders to get ready for launch of improved system in November 2017
Read more online Read
  • 12 June 2017
  • 225
No timeline at FDA for adoption of ICH E6 (R2)
Widler & Schiemann asked the USFDA as no information can be found on their homepage
Read
  • 08 June 2017
  • 202
EMA issues Draft Guideline on Serious Breaches
Breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
Read the pdf Read
  • 04 June 2017
  • 431
China submits conditional application to join ICH
At DIA China Annual Meeting China Secretary Yuan Lin confirmed China’s application
Read more online Read
  • 01 June 2017
  • 307
Widler & Schiemann Ltd. and Beijing Jingwei Chuanqi Medicines Service Ltd. start Joint Venture in China
WS China will be a joint venture together with our partner 3Audit
Read
  • 25 May 2017
  • 217
CFDA prunes medical device standards management guidelines
CFDA amends Medical Device Guideline
Read more online Read
  • 18 May 2017
  • 223
Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials
FDA’s CDER and C-Path’s PRO consortium second workshop
Read more online Read
  • 10 May 2017
  • 262
Summary of changes to the guidance of publication of clinical trial data by EMA
Update to the guidance published on March 03, 2016
Read the pdf Read
  • 05 May 2017
  • 247
The EFPIA Disclosure Experience: An Update
EFPIA offers an update on media and industry responses
Read more online Read
  • 30 April 2017
  • 309
EMA publishes new draft GCP guideline on TMF requirements
The deadline for comments is 11 July 2017
Read the pdf Read
  • 20 April 2017
  • 365
Small and Mid size Biotech Companies’ EDMS
Pocket EDMS URS include now TMF requirements
Read more online Read
  • 15 April 2017
  • 371
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
Read more online Read
  • 10 April 2017
  • 385
China FDA publishes first report on self-inspection rule
Inspection Report for Drug Clinical Trial Data
Read more online Read
  • 05 April 2017
  • 329
New and revised FDA guidances for 2017
CDER’s plan for guidances for 2017
Read more online Read
  • 03 April 2017
  • 328
FDA and EMA to collaborate closer on GMP Inspections
Update to the 1998 agreed mutual recognition agreement
Read more online Read
  • 20 March 2017
  • 380
CFDA sets out principles for generic equivalency clinical trials
Follow up to last years’ release of new Bioequivalence guidelines
Read more online Read
  • 16 March 2017
  • 363
FDA publishes OSI Statistics
OSI (Office of Scientific Investigations) publishes an overview of metrics on their homepage
Read more online Read
  • 12 March 2017
  • 594
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
Read more online Read
  • 08 March 2017
  • 812
EMA invites comment on revised “Document Access Policy”
Comments from stakeholders invited until 18 May 2017
Read more online Read
  • 04 March 2017
  • 672
ICH invites comments on Efficacy Guidelines
ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6
Read more online Read
  • 01 March 2017
  • 342
US Government publishes revision for the protection of human subjects
Widler & Schiemann’s interpretation of the new policy
Read the pdf Read
  • 18 November 2016
  • 80
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
  • 782
Chinese Manufacturers struggle with Quality
While Chinese companies export about 50% of global APIs they struggle with international quality requirements
Read more online Read
  • 20 September 2016
  • 678
Transparency in drug regulation
Publication of assessment reports in Europe and Australia makes information on medicines more easily available
Read more online Read
  • 16 September 2016
  • 648
EU collaboration strengthens safety monitoring of medicines
European Commission publishes three-year report on implementation of pharmacovigilance legislation
Read more online Read
  • 08 September 2016
  • 704
Better monitoring of biological medicines
New chapter in guidelines on good pharmacovigilance practices
Read more online Read
  • 04 September 2016
  • 752
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
Read the pdf Read
  • 20 August 2016
  • 835
FDA issues draft guidance on drug development in rare diseases
This draft guidance is open for comments for the next 60 days.
Read the pdf Read
  • 15 August 2016
  • 857
EMA publishes Pharmacovigilance Report
Annual report of pharmacovigilance inspectors’ working party for 2014
Read the pdf Read
  • 10 August 2016
  • 852
Audits in GCP and Beyond
The third issue of GCP auditing will be released soon
Read more online Read
  • 05 August 2016
  • 932
UK TAKES AIM AT PHARMA PERKS
Sunshine rule announced in the UK
Read
  • 31 July 2016
  • 829
CFDA issues extensive DRR draft amendments
The China FDA invites comments on their latest revision of their Drug Registration Regulation
Read the pdfRead more online Read
  • 31 July 2016
  • 881
European Commission launches EU-U.S. Privacy Shield
A new framework for stronger protection for transatlantic data flow to build trust
Read more online Read
  • 31 July 2016
  • 761
EMA to introduce Public Hearings
Vox Populi at EMA’s PRAC
Read the pdf Read
  • 31 July 2016
  • 792
EMA plans to revise guidance on first-in-human clinical trials
Comments invited on a concept paper on changes intended to support best practices
Read
  • 21 March 2016
  • 924
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.
Read more online Read
  • 14 March 2016
  • 1185
EMA publishes two Drug Safety related Draft Guidance for Consultation
Guideline on Good Pharmacovigilance Practices (GVP) 3 - Module V – Risk management systems (Rev 2)
Read the pdfRead more online Read
  • 07 March 2016
  • 1154
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
Read the pdf Read
  • 03 March 2016
  • 1299
Oliver Hellstern, MD joins Widler & Schiemann
Oliver Hellstern, Expert in Drug Safety, joins Widler & Schiemann Ltd. on March 1st, 2016
Read more online Read
  • 22 February 2016
  • 1296
Stronger data protection rules for Europe
The EU adopts the data protection reform package
Read more online Read
  • 15 February 2016
  • 1221
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.
Read
  • 10 February 2016
  • 1174
Germany: New Anti-Corruption Law
Fighting Private Sector Bribery and Cross-Border Corruption
Read more online Read
  • 09 February 2016
  • 1226
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
Read more online Read
  • 09 February 2016
  • 1282
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
Read the pdf Read
  • 21 January 2016
  • 1163
Endpoint Adjudication Survey Results are in!
The recently launched endpoint adjudication survey results are out:
Read more online Read
  • 14 January 2016
  • 1196
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
Read more online Read
  • 07 January 2016
  • 1075
New FDA Guidance on meetings with Biosimilar Companies
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants: Guidance for Industry
Read the pdf Read
  • 06 January 2016
  • 1125
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
Read the pdf Read
  • 20 December 2015
  • 1352
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
Read
  • 15 December 2015
  • 1152
ACRES and Ethical GmbH, Switzerland to collaborate on eAdjudication
ACRES integrates eAdjudication into shared global platform of integrated technologies
Read
  • 10 December 2015
  • 1401
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
Read
  • 05 December 2015
  • 1170
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
Read the pdf Read
  • 02 December 2015
  • 1211
MHRA wants to see paper records retained
MHRA commented in their discussion forum on retention of trial records
Read more online Read
  • 21 November 2015
  • 1205
Survey on endpoint adjudication launched!
Mimmo Garibbo, Dirctor at Ethical GmbH launches survey on endpoint adjudication
Read more online Read
  • 17 November 2015
  • 266
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
  • 987
Beat Widler co-authors article on adjudication methods
An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals
Read the pdf Read
  • 07 November 2015
  • 1196
ICH goes Risk-based!
Beat Widler co-authors article in Applied Clinical Trials (ACT)
Read more online Read
  • 02 November 2015
  • 1216
CluePoints and Widler & Schiemann announce Partnership
CluePoints and WSQMS signed a partnership agreement to support each other in projects with clients
Read the pdf Read
  • 01 October 2015
  • 1719
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
Read more online Read
  • 01 October 2015
  • 1293
Workshop on Risk-based Monitoring
Artem Andrianov and Peter Schiemann to lead workshop at PCT Conference in November in Hamburg, Germany
Read the pdf Read
  • 01 October 2015
  • 1227
Cheaper Generics for poor Countries
European Commission backs bypassing drug patents for poor nations
Read more online Read
  • 31 August 2015
  • 1955
DIA Global Forum Online August
Contribution on Quality Matters by Beat Widler & Peter Schiemann
Read more online Read
  • 20 August 2015
  • 1600
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.
Read the pdf Read
  • 15 August 2015
  • 1186
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
Read the pdf Read
  • 10 August 2015
  • 1526
Beat Widler authors article on Inspection Readiness
The German Society for Pharmaceutical Medicine published an article by Beat Widler on Inspection Readiness (in German)
Read the pdf Read
  • 05 August 2015
  • 1228
FDA Draft Guidance on Metrics in Manufacturing
FDA released its draft guidance on metrics for manufacturing for comments within the next 60 days
Read the pdf Read
  • 31 July 2015
  • 316
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.
Read the pdf
  • 31 July 2015
  • 1563
EMA to encourage use of Scientific Advice for Post-Authorisation Safety Studies
12-month pilot will support design of high-quality safety studies!
Read more online Read
  • 21 July 2015
  • 1937
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
Read the pdf Read
  • 14 July 2015
  • 1409
FDA’s page on Expanded Access Programs
FDA’s current policies on compassionate use can be found on this homepage
Read more online Read
  • 08 July 2015
  • 260
Embrac­ing RBM, a company’s smaller size can become an advantage

RBM as Competitive Advantage for Mid-sized CROs (White Paper by A. Andrianov)

Read the pdf
  • 07 July 2015
  • 1466
Widler & Schiemann AG support WHO on GCP Training
Two successful workshops conducted in the Philippines and Nigeria
Read
  • 02 July 2015
  • 1720
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
  • 20 June 2015
  • 1768
EMA on Gene Therapy
The European Medicines Agency invites feedback on their latest draft guidance
Read more online Read
  • 15 June 2015
  • 1394
Master Protocols proposed by FDA
FDA’s Woodcock proposes master protocols, infrastructure to increase clinical trial efficiency, reduce costs
Read more online Read
  • 10 June 2015
  • 1714
Beat Widler presents at Drug Development Expert Workshop in Frankfurt, Germany
Risk-based study management – dos and don’ts
Read the pdf Read
You can subscribe to the WSQMS Newsletter here!

Services

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.

Read Download as PDF
Quality Risk Management

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

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
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.

Read Download as PDF
Copyright Widler & Schiemann AG 2015. All Rights Reserved. /