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  • 30 September 2019
  • 1332
NMPA officially joins Medical Device Regulators Forum (IMDRF) National Competent Authorities Report (NCAR) Exchange Program
On September 19, 2019 the IMDRF approved the Chinese National Medical Products Administration (NMPA) to join the IMDRF National Competent Authorities Report (NCAR) Exchange Program.
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  • 30 September 2019
  • 1097
Safer Technologies Program for Medical Devices
FDA issued a draft document of Safer Technologies Program for Medical Devices on September 19, 2019 and opened for public comment until November 18, 2019.
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  • 30 September 2019
  • 1303
EMA EudraVigilance Registration Manual
On September 25, 2019 EMA issued EMA EurdaVigilance Registration Manual.
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  • 30 September 2019
  • 1088
New Organization First User QPPV/RP or Change of EU QPPV/RP
On September 25, 2019 EMA informed that sponsors need to notify EMA in case of new organization first user QPPV/RP or change of EU QPPV/RP.
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  • 30 September 2019
  • 1098
Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorization holders (MAHs)
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) in a no-deal Brexit.
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  • 30 September 2019
  • 1060
Policy for Device Software Functions and Mobile Medical Applications
On September 27, 2019 the FDA issued this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile or on other general-purpose computing platforms.
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  • 30 September 2019
  • 9773
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
FDA issued a final guidance on Medical Device Data Systems for industry and FDA staff on September 27, 2019. The policy described in this guidance document is also consistent with the Agency’s updated guidance entitled “Policy for Device Software Functions and Mobile Medical Applications,” originally issued on February 9, 2015, with the title “Mobile Medical Applications.”
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  • 01 September 2019
  • 1311
Post-marketing Safety Reporting for Combination Products
FDA issued the final guidance for industry and FDA staff on July 22, 2019
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  • 01 September 2019
  • 1120
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry
The US FDA issued the final guidance on the use of placebos and blinding in randomized controlled cancer clinical trials on August 27, 2019
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  • 01 September 2019
  • 1032
The National People's Congress of China issued the 2nd Revision of Drug Administration Law
The new revised Drug Administration Law of China will be effective since December 01, 2019
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  • 01 September 2019
  • 1088
EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorization decisions for new medicines
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  • 01 September 2019
  • 2782
Questions Pile up for Novartis as Senators Call on FDA to Take Action
The importance of having a robust investigation process in place supported by a clear SOP and structured guidance documents on how to conduct an investigation
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  • 01 September 2019
  • 1150
Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal
U.K. MHRA Updates Information Pages in the Event of a No-Deal Brexit on August 6, 2019
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  • 01 September 2019
  • 1137
What’s new in Pharmacovigilance? QPPV Update
EMA published the QPPV Update on August 1, 2019
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  • 01 September 2019
  • 1043
Guideline on Clinical Investigation of Medicinal Products for the Treatment of Gout (Draft)
EMA updated this Draft with the end of consultation on August 31, 2019
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  • 01 September 2019
  • 1027
ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Trials
ICH is announcing a public meeting on E8(R1), to be held on October 31, 2019 at 08:30 a.m. to 5:00 p.m. ET in Silver Spring, Maryland, USA, with Webcast option available.
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  • 01 September 2019
  • 1078
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry
Comments and suggestions regarding this draft document should be submitted by October 30, 2019
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  • 19 July 2019
  • 1158
Why Industry Anticipates a ‘Cliff-Edge’ Scenario with EU MDR/IVDR
Manufacturers and the European Association of Notified Bodies alike face difficult decisions with the new
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  • 18 July 2019
  • 1150
Regulations on Customized Medical Device Supervision and Management (Trial Version) in China
New regulations on customized medical devices in China
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  • 17 July 2019
  • 1066
German Study Finds Most New Drugs Fail to Improve on Standard of Care
Germany’s Institute of Quality and Efficiency in Healthcare (IQWiG) finds there is no evidence of added benefit for more than half of the drugs the institute assessed from 2011-2017.
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  • 17 July 2019
  • 1072
Risk Evaluation and Mitigation Strategies:
Modifications and Revisions Guidance for Industry
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  • 15 July 2019
  • 1313
Population
Pharmacokinetics Guidance for Industry
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  • 15 July 2019
  • 1132
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent
Pregnancy Guidance for Industry
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  • 30 June 2019
  • 1199
One additional country to benefit from EU-US mutual recognition agreement for inspections
Germany Joins EU-US GMP Mutual Recognition Pact
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  • 30 June 2019
  • 1209
Optimisation of Safety Data Collection
This guidance is being distributed for comment purposes only
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  • 30 June 2019
  • 1263
ANDA Submissions — Content and Format of Abbreviated New Drug Applications
Guidance for Industry ensuring a complete, high-quality application submitted to FDA
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  • 30 June 2019
  • 1076
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
This guidance document is being distributed for comment purposes only.
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  • 30 June 2019
  • 1112
Research Investigational New Drug Applications – What You Need To Know
Similarities and differences in submission requirements for Commercial and Research IND
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  • 30 June 2019
  • 1197
China publishes regulation on management of human genetic resources
New rules to regulate genetic research
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  • 30 June 2019
  • 1294
Guidance Document: Pre-market Requirements for Medical Device Cybersecurity
Health Canada’s new premarket requirements on medical device cybersecurity came into effect
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  • 24 June 2019
  • 3062
China to stipulate the accountabilities of Marketing Authorization Holder (MAH)
China released the “Revision of the Drug Administration Law of the People's Republic of China” for public comment
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  • 17 June 2019
  • 1084
China to implement new regulation for on-site inspections at the clinical sites and manufacturing facilities
National Medical Products Administration (NMPA) released “Regulations for on-site inspections at the clinical sites and manufacturing facilities” for public comment
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  • 17 June 2019
  • 1180
EMA Guideline on the quality requirements for drug-device combinations
Documentation expected for Drug-Device Combinations (DDCs)
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  • 17 June 2019
  • 1055
FDA Report on Pharmaceutical Quality
Product Quality of Products marketed in the USA
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  • 17 June 2019
  • 2907
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
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  • 07 June 2019
  • 1348
ICH E8 under revision
The ICH Guideline “General Considerations for Clinical Trials” is under revision and has been issued for public comments
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  • 01 June 2019
  • 1111
Significant advancements in global harmonization efforts at ICH’s largest biannual meeting to-date
Sixteen Members and twenty-eight Observers met in Amsterdam
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  • 21 December 2018
  • 2186
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
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  • 17 December 2018
  • 2036
EMA eSource Direct Data Capture (DDC) qualification opinion issued
the regulatory acceptability to use an eSource Direct Data Capture in Clinical Trials
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  • 10 December 2018
  • 1990
EMA use of patient disease registries for regulatory purposes
Methodological and operational considerations by a cross-committee task force on Registries
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  • 03 December 2018
  • 2025
FDA Facilitates the Use of Surrogate Endpoint in Drug Development
CDER small business and industry assistance podcast news from November 2018
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  • 20 September 2018
  • 3432
EMA Draft questions and answers on Data Monitoring Committees issues
A Supplement to the CHMP Data Monitoring Committee Guideline
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  • 15 September 2018
  • 1710
EMA on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
New Draft Guideline issued; consultation end date: July 2019
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  • 10 September 2018
  • 1758
FDA Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
New FDA Guidance for Industry
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  • 05 September 2018
  • 1566
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
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  • 03 September 2018
  • 2135
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
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  • 16 August 2018
  • 1702
CNDA seeks feedback on latest GCP Regulation Draft
The Chinese National Drug Administration (CNDA) is looking for feedback by August 16, 2018
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  • 12 August 2018
  • 3830
FDA Final Guidance for Industry: ANDA Submissions
Amendments to Abbreviated New Drug Applications under GDUFA
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  • 08 August 2018
  • 1847
FDA Announces Two Initiatives on Quality Metrics Program Development
FDA is looking for feedback on their recent Quality Initiatives on Metrics
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  • 04 August 2018
  • 1933
FDA Publishes List of Surrogate Endpoints Used in Drug Approvals
The list includes surrogate endpoints for approval of new drug applications
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  • 02 August 2018
  • 2057
EMA Policy 70 submissions temporarily suspended as of 1 August
Phase 2 of EMA’s Business Continuity Plan soon to come into effect
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  • 28 July 2018
  • 1552
Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
Publication of updated Q+As and practical guidance
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  • 21 July 2018
  • 1999
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
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  • 14 July 2018
  • 1688
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
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  • 07 July 2018
  • 1766
Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
Agreement now operational between 14 EU Member States and FDA
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  • 20 June 2018
  • 1525
Informed Consent for Pediatric Clinical Trials in Europe 2015 - Updated
Update from May 2018 detailing procedures in all member states
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  • 15 June 2018
  • 1990
Pediatric investigation plans: questions and answers
Detailed guidance for sponsors applying for a pediatric investigation plan (PIP)
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  • 10 June 2018
  • 1858
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
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  • 06 June 2018
  • 2034
USFDA issue new Guidance on Clinical Trial Imaging Endpoint Process Standards
Final Guidance for Industry effective April 2018
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  • 06 June 2018
  • 31243
US FDA issues Institutional Review Board (IRB) Written Procedures
Final Guidance for Institutions and IRBs effective May 2018
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  • 20 May 2018
  • 1749
New EMA Draft Guideline on Clinical Evaluation of Vaccines
Comments can be sent in until 30th October 2018
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  • 16 May 2018
  • 1744
Increasing oversight of API manufacturing through international collaboration
Report on the International API inspection program published
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  • 12 May 2018
  • 1734
USFDA’s Revision 1 of the Special Protocol Assessment Guidance
In Effect: April 2018 – May 2020
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  • 08 May 2018
  • 1710
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
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  • 04 May 2018
  • 1844
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
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  • 02 May 2018
  • 1841
Beat Widler to moderate session at EFGCP Workshop 18th June 2018, London
Investigators meet Inspectors workshop by EFGCP in the light of ICH E6R2
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  • 20 April 2018
  • 2110
New tracking tool for EMA’s relocation to Amsterdam
Tool gives transparent overview of main milestones and work stream deliverables
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  • 15 April 2018
  • 2088
USFDA’s Compliance Policy for Combination Product Post-Marketing Safety Reporting
Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
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  • 10 April 2018
  • 1928
China’s NHFPC and CFDA to be downgraded amid ministerial reshuffle
The National People’s Congress officially approved plans for a ministry shakeup
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  • 05 April 2018
  • 1755
CHMP adopts new Guideline on Good Pharmacogenomic Practice
The new guideline adopted by the CHMP will become effective on 1st September 2018
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  • 31 March 2018
  • 2170
Clinical site initiation process remains lengthy and highly inefficient
New Tufts Center Report
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  • 26 March 2018
  • 2513
China’s CDE clarifies NDA dossier requirements
A wave of PD-1/PD-L1 mAb application pushes CDE to act
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  • 19 March 2018
  • 5412
USFDA releases ICH Q11 guidance Q&A document
ICH Q11 Q&A document specifically about starting materials
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  • 12 March 2018
  • 1841
USFDA releases ICH E6 R2 guidance
ICH guideline issued by the USFDA
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  • 05 March 2018
  • 1883
USFDA BIMO Report presentation issued
The presentation gives an overview on the 2017 inspections and findings
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  • 04 March 2018
  • 2044
General Court confirms EMA approach to transparency
Three rulings clarify the scope of commercial confidentiality with regard to authorized medicines
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  • 19 February 2018
  • 4570
CFDA’s “Orange Book” launch marks new era of quality generics
Standards for generic products will ensure quality throughout the Chinese market
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  • 16 February 2018
  • 2229
CFDA moving to implement greater transparency over drug reviews
As full ICH member CFDA applies international standards
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  • 12 February 2018
  • 2520
CFDA applying ICH technical guidelines to drug filings, safety management
CFDA’s follow up on full ICH membership
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  • 08 February 2018
  • 1957
EMA surveys pharma companies on their preparedness for Brexit
Planning of regulatory steps needed to ensure medicines remain on EU market
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  • 04 February 2018
  • 1872
Best Practices for Communication Between IND Sponsors and USFDA During Drug Development
Guidance for Industry and Review Staff
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  • 01 February 2018
  • 2076
Update: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Guidance for Industry and Food and Drug Administration Staff
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  • 20 January 2018
  • 1968
Small Business and Industry Assistance (SBIA) Documents in Chinese
US FDA provides SBIA documents in Chinese Translation
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  • 16 January 2018
  • 2312
US FDA Draft Guidance: The Least Burdensome Provisions - Concept and Principles
Draft Guidance for Industry and Food and Drug Administration Staff
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  • 12 January 2018
  • 1972
New US FDA Draft Guidance
Refuse to File: NDA and BLA Submissions to CDER
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  • 08 January 2018
  • 2108
Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
EMA and European Commission publish updated Q&As
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  • 04 January 2018
  • 3075
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
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  • 31 December 2017
  • 1982
Henk de Wilde joins Widler & Schiemann Ltd. as Managing Director
Henk de Wilde will join Widler & Schiemann Ltd. in Switzerland in January 2018
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  • 20 December 2017
  • 2220
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
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  • 15 December 2017
  • 2539
New Edition of the International Compilation of Human Research Standards
2018 Edition now available
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  • 10 December 2017
  • 2318
New EudraVigilance system is live
Better safety monitoring for patients across Europe
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  • 05 December 2017
  • 7857
EU-US mutual recognition of inspections of medicines manufacturers enters operational phase
Major milestone is a testimony to mutual trust
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  • 01 December 2017
  • 2271
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
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  • 20 November 2017
  • 2202
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”
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  • 16 November 2017
  • 2415
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
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  • 12 November 2017
  • 2112
Updates on EMA Guideline on Good Pharmacovigilance Practice
Two of the updated Modules will become effective in November 2017
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  • 08 November 2017
  • 2010
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)
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  • 04 November 2017
  • 2043
Update on USFDA Draft Guidance on REMS
Update on format and content of a REMS document – Revision of the 2009 Guidance
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  • 01 November 2017
  • 2492
Widler & Schiemann open China Office
Business license obtained, first employee hired
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  • 24 October 2017
  • 7165
New Pharmacovigilance (PV) Inspection Guide by Australian Health Authority
The Therapeutics Goods Administration (TGA) issued a new guidance for medicine sponsors on PV
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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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