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.

Our Services

Download as PDF
  • 17 June 2019
  • 1472
FDA Report on Pharmaceutical Quality
Product Quality of Products marketed in the USA
Read more online Read
  • 17 June 2019
  • 3288
RWD & RWE in FDA submissions
New Draft Guideline on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
Read more online Read
  • 07 June 2019
  • 1855
ICH E8 under revision
The ICH Guideline “General Considerations for Clinical Trials” is under revision and has been issued for public comments
  • 01 June 2019
  • 1478
Significant advancements in global harmonization efforts at ICH’s largest biannual meeting to-date
Sixteen Members and twenty-eight Observers met in Amsterdam
Read the pdf Read
  • 21 December 2018
  • 2551
China makes switch to faster approval system for imported drugs
NMPA and National Health Commission of China have established faster system to review and approve on urgently needed new drugs that have been approved in other countries
  • 17 December 2018
  • 2481
EMA eSource Direct Data Capture (DDC) qualification opinion issued
the regulatory acceptability to use an eSource Direct Data Capture in Clinical Trials
Read the pdf Read
  • 10 December 2018
  • 2363
EMA use of patient disease registries for regulatory purposes
Methodological and operational considerations by a cross-committee task force on Registries
Read more online Read
  • 03 December 2018
  • 2397
FDA Facilitates the Use of Surrogate Endpoint in Drug Development
CDER small business and industry assistance podcast news from November 2018
Read more online Read
  • 20 September 2018
  • 3935
EMA Draft questions and answers on Data Monitoring Committees issues
A Supplement to the CHMP Data Monitoring Committee Guideline
Read more online Read
  • 15 September 2018
  • 2099
EMA on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
New Draft Guideline issued; consultation end date: July 2019
Read more online Read
  • 10 September 2018
  • 2115
FDA Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
New FDA Guidance for Industry
Read the pdf Read
  • 05 September 2018
  • 1998
New FDA Draft Guidance on Hematologic Malignancy and Oncologic Disease
Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development
Read the pdf Read
  • 03 September 2018
  • 2603
New FDA draft Guidance on Expansion Cohorts
Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
Read the pdf Read
  • 16 August 2018
  • 2068
CNDA seeks feedback on latest GCP Regulation Draft
The Chinese National Drug Administration (CNDA) is looking for feedback by August 16, 2018
  • 12 August 2018
  • 4294
FDA Final Guidance for Industry: ANDA Submissions
Amendments to Abbreviated New Drug Applications under GDUFA
Read the pdfRead more online Read
  • 08 August 2018
  • 2248
FDA Announces Two Initiatives on Quality Metrics Program Development
FDA is looking for feedback on their recent Quality Initiatives on Metrics
  • 04 August 2018
  • 2297
FDA Publishes List of Surrogate Endpoints Used in Drug Approvals
The list includes surrogate endpoints for approval of new drug applications
  • 02 August 2018
  • 2447
EMA Policy 70 submissions temporarily suspended as of 1 August
Phase 2 of EMA’s Business Continuity Plan soon to come into effect
Read the pdf Read
  • 28 July 2018
  • 1912
Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
Publication of updated Q+As and practical guidance
Read more online Read
  • 21 July 2018
  • 2360
Re-issuing of USFDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA (Biosimilar User Fee Act) Products
Comments are encouraged within 90 days of issuance
Read the pdf Read
  • 14 July 2018
  • 2041
New FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
Draft Guidance published for receiving comments within 60 days
Read the pdf Read
  • 07 July 2018
  • 2254
Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
Agreement now operational between 14 EU Member States and FDA
Read more online Read
  • 20 June 2018
  • 1872
Informed Consent for Pediatric Clinical Trials in Europe 2015 - Updated
Update from May 2018 detailing procedures in all member states
Read the pdf Read
  • 15 June 2018
  • 2411
Pediatric investigation plans: questions and answers
Detailed guidance for sponsors applying for a pediatric investigation plan (PIP)
Read more online Read
  • 10 June 2018
  • 2285
EMA draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice
EMA asks for comments on the new guideline by end of August 2018
Read more online Read
  • 06 June 2018
  • 2449
USFDA issue new Guidance on Clinical Trial Imaging Endpoint Process Standards
Final Guidance for Industry effective April 2018
Read the pdf Read
  • 06 June 2018
  • 34238
US FDA issues Institutional Review Board (IRB) Written Procedures
Final Guidance for Institutions and IRBs effective May 2018
Read more online Read
  • 20 May 2018
  • 2110
New EMA Draft Guideline on Clinical Evaluation of Vaccines
Comments can be sent in until 30th October 2018
Read the pdf Read
  • 16 May 2018
  • 2176
Increasing oversight of API manufacturing through international collaboration
Report on the International API inspection program published
Read more online Read
  • 12 May 2018
  • 2120
USFDA’s Revision 1 of the Special Protocol Assessment Guidance
In Effect: April 2018 – May 2020
Read the pdf Read
  • 08 May 2018
  • 2068
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
Read the pdf Read
  • 04 May 2018
  • 2203
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
Read the pdf Read
  • 02 May 2018
  • 2231
Beat Widler to moderate session at EFGCP Workshop 18th June 2018, London
Investigators meet Inspectors workshop by EFGCP in the light of ICH E6R2
Read more online Read
  • 20 April 2018
  • 2491
New tracking tool for EMA’s relocation to Amsterdam
Tool gives transparent overview of main milestones and work stream deliverables
Read more online Read
  • 15 April 2018
  • 2487
USFDA’s Compliance Policy for Combination Product Post-Marketing Safety Reporting
Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
Read the pdf Read
  • 10 April 2018
  • 2323
China’s NHFPC and CFDA to be downgraded amid ministerial reshuffle
The National People’s Congress officially approved plans for a ministry shakeup
Read more online Read
  • 05 April 2018
  • 2232
CHMP adopts new Guideline on Good Pharmacogenomic Practice
The new guideline adopted by the CHMP will become effective on 1st September 2018
Read the pdf Read
  • 31 March 2018
  • 2596
Clinical site initiation process remains lengthy and highly inefficient
New Tufts Center Report
Read the pdf Read
  • 26 March 2018
  • 3058
China’s CDE clarifies NDA dossier requirements
A wave of PD-1/PD-L1 mAb application pushes CDE to act
  • 19 March 2018
  • 6128
USFDA releases ICH Q11 guidance Q&A document
ICH Q11 Q&A document specifically about starting materials
Read the pdf Read
  • 12 March 2018
  • 2237
USFDA releases ICH E6 R2 guidance
ICH guideline issued by the USFDA
Read the pdf Read
  • 05 March 2018
  • 2272
USFDA BIMO Report presentation issued
The presentation gives an overview on the 2017 inspections and findings
Read the pdf Read
  • 04 March 2018
  • 2455
General Court confirms EMA approach to transparency
Three rulings clarify the scope of commercial confidentiality with regard to authorized medicines
Read more online Read
  • 19 February 2018
  • 5284
CFDA’s “Orange Book” launch marks new era of quality generics
Standards for generic products will ensure quality throughout the Chinese market
  • 16 February 2018
  • 2680
CFDA moving to implement greater transparency over drug reviews
As full ICH member CFDA applies international standards
  • 12 February 2018
  • 3074
CFDA applying ICH technical guidelines to drug filings, safety management
CFDA’s follow up on full ICH membership
  • 08 February 2018
  • 2321
EMA surveys pharma companies on their preparedness for Brexit
Planning of regulatory steps needed to ensure medicines remain on EU market
Read more online Read
  • 04 February 2018
  • 2240
Best Practices for Communication Between IND Sponsors and USFDA During Drug Development
Guidance for Industry and Review Staff
Read the pdfRead more online Read
  • 01 February 2018
  • 2442
Update: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Guidance for Industry and Food and Drug Administration Staff
Read the pdf Read
  • 20 January 2018
  • 2360
Small Business and Industry Assistance (SBIA) Documents in Chinese
US FDA provides SBIA documents in Chinese Translation
  • 16 January 2018
  • 2665
US FDA Draft Guidance: The Least Burdensome Provisions - Concept and Principles
Draft Guidance for Industry and Food and Drug Administration Staff
Read the pdf Read
  • 12 January 2018
  • 2379
New US FDA Draft Guidance
Refuse to File: NDA and BLA Submissions to CDER
Read the pdf Read
  • 08 January 2018
  • 2584
Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
EMA and European Commission publish updated Q&As
Read more online Read
  • 04 January 2018
  • 3480
EMA adopts ICH guideline E17
ICH guideline E17 on general principles for planning and design of multi-regional clinical trials coming into effect in June 2018
Read more online Read
  • 31 December 2017
  • 2358
Henk de Wilde joins Widler & Schiemann Ltd. as Managing Director
Henk de Wilde will join Widler & Schiemann Ltd. in Switzerland in January 2018
Read more online Read
  • 20 December 2017
  • 2584
USFDA Widens Scope of Navigator – Information Tool for Expanded Access
Two examples of the recent steps US FDA has taken in pursuit of improving their expanded access and orphan drug program
Read more online Read
  • 15 December 2017
  • 2932
New Edition of the International Compilation of Human Research Standards
2018 Edition now available
Read the pdf Read
  • 10 December 2017
  • 2710
New EudraVigilance system is live
Better safety monitoring for patients across Europe
Read more online Read
  • 05 December 2017
  • 8216
EU-US mutual recognition of inspections of medicines manufacturers enters operational phase
Major milestone is a testimony to mutual trust
Read the pdfRead more online Read
  • 01 December 2017
  • 2658
Xi Chen joins Widler & Schiemann Ltd. China as Managing Director
Ms. Xi Chen, MSc, MBA, has joined WS China with more than 20 years of industry experience
  • 20 November 2017
  • 2609
China will allow private hospitals and other health related institutions
In his speech at the 19th National Congress of the CPC, President Xi Jinping emphasized the focus on “Healthy China”
  • 16 November 2017
  • 2912
China now accepting Clinical Trial Data from other Countries
CFDA issued a new guideline announcing that for submissions clinical trial data from other countries will be accepted
  • 12 November 2017
  • 2537
Updates on EMA Guideline on Good Pharmacovigilance Practice
Two of the updated Modules will become effective in November 2017
Read more online Read
  • 08 November 2017
  • 2369
New USFDA Draft Guidance on ANDA and 505(b)(2) Application
USFDA provides a guide for decision making whether to submit an ANDA or 505(b)(2)
Read the pdf Read
  • 04 November 2017
  • 2423
Update on USFDA Draft Guidance on REMS
Update on format and content of a REMS document – Revision of the 2009 Guidance
Read the pdf Read
  • 01 November 2017
  • 2932
Widler & Schiemann open China Office
Business license obtained, first employee hired
  • 24 October 2017
  • 7637
New Pharmacovigilance (PV) Inspection Guide by Australian Health Authority
The Therapeutics Goods Administration (TGA) issued a new guidance for medicine sponsors on PV
Read the pdf Read
  • 18 October 2017
  • 5432
China FDA to issue catalogue of all drugs marketed in China
A Chinese Version of the USFDA’s “Orange Book” will be available soon
  • 14 October 2017
  • 2459
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
  • 2454
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
  • 2539
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
  • 3006
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
  • 16 September 2017
  • 7608
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
  • 2907
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
  • 2495
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
  • 2698
Read the pdf Read
  • 01 September 2017
  • 4378
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
  • 2337
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
  • 2632
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
  • 2629
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
  • 2642
USFDA aims to foster generic drugs
A recent email announcement by USFDA lists the details
  • 04 August 2017
  • 3475
Update of the BIMO Guidance Manual
USFDA announced that a major revision BIMO manual was issued in April 2017 – Guidance for FDA staff
  • 31 July 2017
  • 2557
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
  • 2855
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
  • 2718
Brookwood Academy launches “PV Training for All” Module
EFGCP GCP Discussion Group reviewed the first module
Read more online Read
  • 15 July 2017
  • 2578
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
  • 2432
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
  • 2541
UK’s withdrawal from the EU
EMA publishes first thoughts on implications and mitigating actions.
Read more online Read
  • 04 July 2017
  • 2935
China announced official ICH member
At the ICH Meeting in Montreal, China’s ICH membership was confirmed
Read the pdf Read
  • 01 July 2017
  • 3046
Canada sets date for implementation of ICH E6 R2
The date shall be the 1st April 2018
Read more online Read
  • 20 June 2017
  • 2520
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
  • 2294
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
  • 2832
No timeline at FDA for adoption of ICH E6 (R2)
Widler & Schiemann asked the USFDA as no information can be found on their homepage
  • 08 June 2017
  • 2704
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
  • 3699
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
  • 3571
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
  • 25 May 2017
  • 2732
CFDA prunes medical device standards management guidelines
CFDA amends Medical Device Guideline
Read more online Read
  • 18 May 2017
  • 2555
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
  • 2514
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
  • 2657
The EFPIA Disclosure Experience: An Update
EFPIA offers an update on media and industry responses
Read more online Read
You can subscribe to the WSQMS Newsletter here!


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 2022. All Rights Reserved. /