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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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  • 17 November 2020
  • 7435
Information on the Member States Requirement for the Nomination of a Pharmacovigilance (PhV) Contact Person at National Level
On 11 November 2020 the EMA PhV Inspectors Working Group (IWG) updated the information on PhV contact person.
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  • 17 November 2020
  • 1300
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
On 13 November 2020 the FDA issued the final guidance for industry.
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  • 17 November 2020
  • 1034
Certificates of Confidentiality
On 13 November 2020 the FDA issued the final guidance for sponsors, sponsor-investigators, researchers, industry, and FDA staff.
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  • 17 November 2020
  • 1055
Consideration on Core Requirements for Risk Management Plans of COVID-19 Vaccines —CoreRMP19 Guidance
On 13 November 2020 the EMA issued the new guidance on risk management plans (RMPs) for COVID-19 vaccines.
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  • 03 November 2020
  • 1108
Technical Requirements for Clinical Development of Overseas-marketed and Domestic-non-marketed Products
On 12 October 2020 the Chinese CDE of NMPA issued notification No. 29 on technical requirements.
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  • 03 November 2020
  • 1000
EMA Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
On 19 October 2020 the EMA issued guidance revision 10 addressing a number of questions that users of the scientific advice or protocol assistance procedures may have.
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  • 03 November 2020
  • 972
Reflection Paper on the Pharmaceutical Development of Medicines for Use in the Older Population
On 22 October 2020 the EMA issued this reflection paper for medicine developers.
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  • 03 November 2020
  • 1154
Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF) from 1 January 2021
On 23 October 2020 the MHRA updated guidance on the QPPV and PSMF for UK authorized products.
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  • 03 November 2020
  • 1137
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
On 20 October 2020 the FDA announced the availability of the draft guidance for industry.
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  • 03 November 2020
  • 1041
Updated Guidance on Pharmacovigilance (PV) Procedures
On 27 October 2020 the MHRA published the updated guidance on PV procedures.
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  • 03 November 2020
  • 1088
Referencing Approved Drug Products in ANDA Submissions
On 27 October 2020 the FDA announced the availability of the final guidance for industry.
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  • 03 November 2020
  • 952
Providing Regulatory Submissions in Electronic Format — Standardized Study Data
On 29 October 2020 the FDA announced the availability of the final guidance for industry.
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  • 21 October 2020
  • 1002
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment
On 1 October 2020 the FDA announced the availability of the final guidance for industry.
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  • 21 October 2020
  • 1108
EMA Updated the Status of Clinical Trials Information System (CTIS)
On 5 October 2020 the EMA announced that the audit of the clinical trial information system (CTIS) will commence in November 2020.
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  • 21 October 2020
  • 1229
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
On 7 October 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 7 December 2020.
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  • 21 October 2020
  • 999
MHRA Guidance on the Licensing of Biosimilar Products
On 7 October 2020 the MHRA published the open consultation document.
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  • 21 October 2020
  • 984
Checklist for Annual Updates for Parallel Distribution
On 8 October 2020 the EMA announced the availability of the guidance for industry.
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  • 21 October 2020
  • 1021
Questions and Answers on Data Monitoring Committees Issues
On 8 October 2020 the EMA published the Q&A document on DMC issues.
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  • 21 October 2020
  • 1275
Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
On 15 October 2020 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted until 15 December 2020.
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  • 21 October 2020
  • 948
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
On 15 October 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 21 October 2020
  • 7056
Testing for Biotin Interference in In Vitro Diagnostic Devices
On 15 October 2020 the FDA announced the availability of the final guidance for industry.
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  • 21 October 2020
  • 1041
Updated IRIS Guide for Applicants
On 15 October 2020 the EMA updated the IRIS guide on how to create and submit scientific applications for industry and individual applicants.
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  • 21 October 2020
  • 916
WSQMS Managing Partner Dr. Beat Widler Key Speaker at 20-year Anniversary of Swiss Centers China in Neuchatel
On 16 October 2020 the Swiss Centers China celebrated its 20-year anniversary in Neuchatel Switzerland.
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  • 21 October 2020
  • 956
Estelle Chao Promoted to Managing Director APAC at Widler & Schiemann Ltd. Shanghai
On 19 October 2020 WSQMS Managing Partner Dr. Peter Schiemann announced the promotion of Estelle Chao to Managing Director APAC with immediate effect.
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  • 05 October 2020
  • 999
Export Certificates and Manufacturing Certificates for Medical Devices
On 30 July 2020 the Swissmedic published the information sheet about issuing export and manufacturing certificates for medical devices.
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  • 05 October 2020
  • 1003
Authorizations for Non-conforming Medical Devices
On 1 August 2020 the Swissmedic published the information sheet about the authorizations for non-conforming medical devices.
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  • 05 October 2020
  • 7087
Eosinophilic Esophagitis: Developing Drugs for Treatment
On 15 September 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 October 2020
  • 1043
Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry
On 15 September 2020 the FDA announced the availability of the draft guidance for industry. Comments may submit by 16 November 2020.
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  • 05 October 2020
  • 1288
Inclusion/Exclusion Criteria for the “Important Medical Events” List
On 18 September 2020 the EMA published the inclusion/exclusion criteria for the “Important Medical Events” list.
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  • 05 October 2020
  • 1031
European Medicines Regulatory Network (EMRN) COVID-19 Business Continuity Plan
On 18 September 2020 the EMA announced the availability of the updated EMRN COVID-19 business continuity plan.
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  • 05 October 2020
  • 1064
Guideline on Registry-based Studies
On 24 September 2020 the EMA issued the draft guideline on registry-based studies.
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  • 05 October 2020
  • 1034
The ICH Q3D(R2) Draft Guideline Available Now on the ICH Website
On 25 September 2020 the ICH Q3D(R2) draft guideline on elemental impurities reached step 2 of the ICH process.
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  • 05 October 2020
  • 1001
Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 28 September 2020 the FDA updated the final guidance for industry, investigators, and institutional review boards.
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  • 05 October 2020
  • 1688
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
On 28 September 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 October 2020
  • 1000
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
On 28 September 2020 the FDA announced the availability of the draft guidance for industry.
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  • 05 October 2020
  • 941
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
On 29 September 2020 the FDA announced the availability of the draft guidance for industry. Comments can be submitted until 30 November 2020.
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  • 17 September 2020
  • 1355
MHRA Post-Transition Period Information
On 1 September 2020 the UK MHRA published guidance for industry and organizations to follow from 1 January 2021.
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  • 17 September 2020
  • 979
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling
On 3 September 2020 the FDA announced the availability of the draft final guidance for industry.
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  • 17 September 2020
  • 2008
Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process"
On 4 September 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 17 September 2020
  • 1008
Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency
On 10 September 2020 the FDA announced the availability of the guidance for industry.
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  • 17 September 2020
  • 1134
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
On 14 September 2020 the FDA announced the availability of the guidance for industry.
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  • 17 September 2020
  • 1056
Recognition and Withdrawal of Voluntary Consensus Standards
On 14 September 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 02 September 2020
  • 1291
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment
On 17 August 2020 the FDA announced the availability of the draft guidance for industry.
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  • 02 September 2020
  • 1007
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)
On 18 August 2020 the FDA announced the availability of the guidance for industry.
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  • 02 September 2020
  • 1016
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
On 19 August 2020 the FDA announced the availability of the guidance for industry.
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  • 02 September 2020
  • 1072
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
On 25 August 2020 the FDA announced the availability of the draft guidance for industry.
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  • 02 September 2020
  • 1332
Quick Interactive Guide to IRIS Registration Process
On 25 August 2020 the EMA announced the availability of the quick interactive guidance.
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  • 02 September 2020
  • 5026
Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers
On 27 August 2020 the ICH E14/S7B Implementation Working Group (IWG) announced the availability of the ICH E14/S7B Draft Q&As.
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  • 02 September 2020
  • 978
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
On 28 August 2020 the FDA announced the availability of the draft guidance for industry and FDA staff, and other stakeholders.
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  • 17 August 2020
  • 1048
MHRA Regulatory Flexibilities Resulting from Coronavirus (COVID-19)
On 4 August 2020 the UK MHRA updated the guidance for industry on flexible approaches to regulations taken during the COVID-19 outbreak.
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  • 17 August 2020
  • 1529
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format
On 10 August 2020 the FDA announced the availability of the final guidance for industry.
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  • 17 August 2020
  • 1164
EMA Updated Post-Authorisation Safety Studies (PASS)
On 10 August 2020 the EMA updated post-authorisation safety studies.
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  • 17 August 2020
  • 1364
MHRA’s Expectations for Return to UK On-site Inspections
On 11 August 2020 the MHRA published the guidance for industry on planning to resume on-site UK risk-based GxP inspections in September.
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  • 17 August 2020
  • 1072
Drug-Drug Interaction Assessment for Therapeutic Proteins
On 12 August 2020 the FDA announced the availability of the draft guidance for industry.
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  • 17 August 2020
  • 965
Male Breast Cancer: Developing Drugs for Treatment
On 12 August 2020 the FDA announced the availability of the guidance for industry.
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  • 17 August 2020
  • 2074
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
On 12 August 2020 the FDA announced the availability of the guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff.
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  • 03 August 2020
  • 4307
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
On 21 July 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 03 August 2020
  • 1227
EMA Updated EudraVigilance Registration Manual
On 21 July 2020 the EMA announced the availability of the updated EudraVigilance registration manual.
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  • 03 August 2020
  • 1067
MHRA Planning for Return to On-site Good Practice (GxP) Inspections
On 23 July 2020 it was published on the MHRA Inspectorate Blog that MHRA is planning for return to on-site GxP inspections.
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  • 03 August 2020
  • 1200
EMA Updated the GCP Q&A
On 24 July 2020 the EMA updated the GCP Q&A.
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  • 03 August 2020
  • 1313
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
On 29 July 2020 the FDA issued the final guidance for industry.
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  • 03 August 2020
  • 1176
Multiple Function Device Products: Policy and Considerations
On 29 July 2020 the FDA issued the final guidance for industry and FDA staff.
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  • 03 August 2020
  • 2471
MHRA Updated Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol
On 31 July 2020 the UK MHRA announced the availability of the updated guidance.
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  • 03 August 2020
  • 1526
Global Regulatory Workshop on COVID-19 Therapeutics #2: Agreement on Acceptable Endpoints for Clinical Trials
On 31 July 2020 the international regulators published a report on the acceptability of various primary endpoints in the clinical trials conducted for the development of treatments for COVID-19.
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  • 16 July 2020
  • 1147
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
On 1 July 2020 the FDA issued the immediately in effect guidance for industry and FDA staff.
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  • 16 July 2020
  • 1049
Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 2 July 2020 the FDA updated the final guidance for industry, investigators and IRBs.
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  • 16 July 2020
  • 1145
Annual Report of the Pharmacovigilance Inspectors Working Group for 2018
On 2 July 2020 the EMA announced the availability of the 2018 PV annual report.
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  • 16 July 2020
  • 2142
Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 3 July 2020 the EMA published revision 8 of the guidance for sponsors.
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  • 16 July 2020
  • 1291
Technical Notice to Sponsors Regarding Continuous Compliance with the EU Legislation for Clinical Trials Following the Withdrawal of the United Kingdom from the EU
On 9 July 2020 a joint technical notice to sponsors by the European Commission, EMA and HMA was published.
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  • 16 July 2020
  • 1078
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients
On 10 July 2020 the FDA announced the availability of the final guidance for industry and IRBs.
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  • 16 July 2020
  • 1228
China NMPA Guidance on the Management of Clinical Trials of Medical Products During COVID-19 Pandemic
On 14 July 2020 the Chine NMPA issued the draft guidance in Chinese for sponsors and investigators.
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  • 16 July 2020
  • 1050
Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
On 15 July 2020 the FDA issued the final guidance for industry and FDA staff.
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  • 02 July 2020
  • 1111
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
On 16 June 2020 the FDA announced the availability of the final guidance for industry, FDA staff, and other stakeholders.
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  • 02 July 2020
  • 982
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
On 17 June 2020 the FDA announced the availability of the final guidance for industry.
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  • 02 July 2020
  • 1162
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing
On 19 June 2020 the FDA announced the availability of the final guidance for industry.
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  • 02 July 2020
  • 1124
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers
On 22 June 2020 the FDA published the final guidance on the Q&A for industry and FDA staff.
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  • 02 July 2020
  • 1160
Review and Update of Device Establishment Inspection Processes and Standards
On 26 June 2020 the FDA announced the availability of the final guidance for industry.
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  • 02 July 2020
  • 1067
Risk Evaluation and Mitigation Strategies: Modifications and Revisions
On 29 June 2020 the FDA announced the availability of the final guidance for industry.
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  • 02 July 2020
  • 1054
Points to Consider on Implications of Coronavirus Disease (COVID-19) on Methodological Aspects of Ongoing Clinical Trials
On 29 June 2020 the EMA announced the availability of this guidance.
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  • 02 July 2020
  • 1149
Pharmacovigilance Inspection Program Risk Assessment Survey
On 30 June 2020 the Australian TGA announced that the PVIP Risk Assessment Survey is open for medicine sponsors to complete.
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  • 02 July 2020
  • 1162
Widler & Schiemann GmbH Germany Goes Live with Dr. Andreas Fischer, Managing Director
On 1 July 2020 Widler & Schiemann AG Announced New German Subsidiary.
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  • 18 June 2020
  • 1188
Questions and Answers: Qualification of Digital Technology-based Methodologies to Support Approval of Medicinal Products
On 1 June 2020 the EMA updated the Q&A document on the successful qualification of digital technology-based methodologies intended to support approval of medicinal products.
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  • 18 June 2020
  • 36740
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators
On 2 June 2020 the FDA announced the availability of this guidance for IRBs and clinical investigators.
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  • 18 June 2020
  • 1242
FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19
On 2 June 2020 the EMA and FDA published the joint document for medicine developers planning to submit an iPSP and PIP.
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  • 18 June 2020
  • 1106
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 5 June 2020 the FDA announced the availability of this guidance for industry and FDA administration staff.
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  • 18 June 2020
  • 1061
Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency
On 8 June 2020 the FDA announced the availability of this guidance for industry.
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  • 18 June 2020
  • 1607
The Electronic Common Technical Document (eCTD) v4.0 Q&A v1.3 reaches Step 4 of the ICH Process
On 8 June 2020 the ICH announced that ICH eCTD v4.0 Q&A v1.3 document reached Step 4.
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  • 18 June 2020
  • 1216
Guidance on Remote GCP Inspections During the COVID-19 Pandemic
On 10 June 2020 the EMA announced that guidance is available for inspectors on how to initiate and conduct remote inspections to verify compliance with GCP standards during the COVID-19 pandemic.
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  • 18 June 2020
  • 1063
EMA Annual Report 2019 Published
On 15 June 2020 the EMA released its annual report highlighting the most significant achievements in 2019.
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  • 04 June 2020
  • 1190
Summary of Stakeholder Engagement to Support the Development of ICH E6(R3)
On 18 May 2020 the ICH announced the availability of the summary of the E6(3) stakeholder engagement approach.
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  • 04 June 2020
  • 1184
European Medicines Agency Post-authorisation Procedural Advice for Users of the Centralised Procedure
On 18 May 2020 the EMA updated the questions and answers on extensions of marketing authorisations.
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  • 04 June 2020
  • 1549
EMA Updates EudraVigilance Registration Manual
On 18 May 2020 the EMA updated the EudraVigilance registration manual.
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  • 04 June 2020
  • 1186
Clinical Pharmacology and Pharmacokinetics: Questions and Answers
On 25 May 2020 the EMA updated the Q&A document on clinical pharmacology and pharmacokinetics.
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  • 04 June 2020
  • 1014
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers
On 26 May 2020 the FDA published this Q&A Guidance for Industry.
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  • 04 June 2020
  • 1193
Qualification of digital technology-based methodologies to support approval of medicinal products: Questions and Answers
On 27 May 2020 the EMA published the Q&A document on qualification of digital technologies.
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  • 04 June 2020
  • 1143
FDA Provides Free Method to Obtain Informed Consent Electronically for Eligible Clinical Trials During the COVID-19 Public Health Emergency
On 29 May 2020 the FDA announced the availability of the free COVID MyStudies Application (App) for obtaining informed consent remotely.
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  • 18 May 2020
  • 1147
MHRA GCP Inspections Metrics Report: 1st April 2017 – 31st March 2018
On 4 May 2020 the UK MHRA issued the GCP inspection metrics report covering the period 1st April 2017 to 31st March 2018.
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  • 18 May 2020
  • 1561
Australian TGA Pharmacovigilance Inspection Program Metrics Report: January – December 2019
On 4 May 2020 the Health Department of the Australian Government TGA published the metrics report of pharmacovigilance inspections during 2019.
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  • 18 May 2020
  • 1227
Updated Detailed Guidance on ICSRs in the Context of COVID-19: Validity and Coding of ICSRs
On 4 May 2020 the EMA updated the detailed guidance on ICSRs with additional COVID-19 related terms.
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  • 18 May 2020
  • 2805
Explanatory Note to GVP Module VII
On 4 May 2020 the EMA updated the guideline on GVP module VII – Periodic Safety Update Report (PSUR).
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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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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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