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  • 17 September 2020
  • 8
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
  • 8
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
  • 6
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
  • 6
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
  • 11
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
  • 9
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
  • 80
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On 17 August 2020 the FDA announced the availability of the draft guidance for industry.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
  • 70
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
  • 73
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
  • 67
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
  • 91
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
  • 71
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
  • 62
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
  • 130
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
  • 101
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
  • 106
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
  • 94
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
  • 103
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
  • 96
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
  • 97
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
  • 192
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
  • 144
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
  • 138
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
  • 141
EMA Updated the GCP Q&A
On 24 July 2020 the EMA updated the GCP Q&A.
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  • 03 August 2020
  • 132
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
  • 140
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
  • 132
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
  • 139
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
  • 176
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
  • 149
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
  • 166
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
  • 232
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
  • 196
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
  • 159
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
  • 163
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
  • 146
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
  • 196
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
  • 175
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
  • 232
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
  • 217
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
  • 210
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
  • 188
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
  • 188
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
  • 174
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
  • 150
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
  • 265
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
  • 517
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
  • 230
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
  • 245
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
  • 204
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
  • 434
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
  • 226
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
  • 216
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
  • 231
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
  • 228
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
  • 326
EMA Updates EudraVigilance Registration Manual
On 18 May 2020 the EMA updated the EudraVigilance registration manual.
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  • 04 June 2020
  • 233
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
  • 205
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
  • 250
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
  • 234
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
  • 287
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
  • 252
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
  • 240
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
  • 335
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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  • 18 May 2020
  • 292
EMA SME Office Newsletter – Issue 49
On 7 May 2020 the EMA published the SME Office newsletter for small and medium-sized enterprises (SMEs).
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  • 18 May 2020
  • 249
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 14 May 2020 the FDA updated the guidance for Industry, Investigators, and Institutional Review Boards.
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  • 18 May 2020
  • 276
Annual Report of the Good Clinical Practice Inspectors’ Working Group 2018
On 14 May 2020 the EMA published the annual report adopted by the GCP Inspectors’ Working Group (IWG) on 12 March 2020.
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  • 18 May 2020
  • 245
EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines
On 15 May 2020 the EMA announced the availability of the guidance on how EMA fast-tracks development support and approval of medicines and vaccines against COVID-19.
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  • 04 May 2020
  • 272
Fighting the Coronavirus together with the Corona Science App
On 15 April 2020 the Coronavirus Science App developed by Bern University of Applied Sciences and MIDATA was launched to fight the coronavirus together.
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  • 04 May 2020
  • 240
Detailed Guidance on ICSRs in the context of COVID-19
On 21 April 2020 the EMA published the detailed guidance on ICSRs associated with medicinal products used for COVID-19 infection.
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  • 04 May 2020
  • 341
EMA updated EudraVigilance Registration Manual
On 23 April 2020 the EMA published the updated EudraVigilance registration manual.
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  • 04 May 2020
  • 260
eCopy Program for Medical Device Submissions
On 27 April 2020 the FDA issued the updated version of the guidance for industry and FDA staff providing clarification to the processing and technical standards for eCopies based on FDA’s experience to date with the program.
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  • 04 May 2020
  • 237
Updated Guidance on the Management of Clinical Trials during the Covid-19 (Coronavirus) Pandemic
On 28 April 2020 the EMA updated the Good Clinical Practice guidance on distributor to trial participant IMP shipment, monitoring, remote source data verification and communication with authorities.
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  • 04 May 2020
  • 249
Union Procedure on the Follow-up of Pharmacovigilance Inspections
On 30 April 2020 the EMA published this guideline effective 1 May 2020.
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  • 04 May 2020
  • 241
International Compilation of Human Research Standards 2020 Edition
The Office for Human Research Protections U.S. Department of Health and Human Services compiled the 2020 edition of the international compilation of human research standards.
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  • 04 May 2020
  • 236
New Branch of Widler & Schiemann AG in Germany
Widler & Schiemann AG announced Dr. Andreas Fischer will join as Managing Director for their new German affiliate opening on July 1st this year.
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  • 04 May 2020
  • 258
Welcome Dr. Axel Thiele to join Widler & Schiemann AG as Associate Partner
In April 2020 Dr. Axel Thiele joined Widler & Schiemann AG as Associate Partner. His joining strengthens our expertise in Pharmacovigilance.
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  • 16 April 2020
  • 274
ICH M1 Points to Consider Working Group and MedDRA MSSO Communication on Coronavirus
On 1 April 2020 the ICH announced the notification on MedDRA terms for coronavirus concepts now available
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  • 16 April 2020
  • 282
Global Coronavirus COVID-19 Clinical Trial Tracker
Cytel announced the launch of an open-access global COVID-19 Clinical Trial Tracker.
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  • 16 April 2020
  • 230
Notice to Sponsors on Validation and Qualification of Computerised Systems Used in Clinical Trials
On 7 April 2020 the EMA provided guidance in forms of questions and answers (Q&As) on GCP.
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  • 16 April 2020
  • 236
Overview of Comments Received on ICH Guideline E8 (R1) on General Considerations for Clinical Studies
On 7 April 2020 the EMA published an overview of comments received from 40 stakeholders on ICH guideline E8(R1).
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  • 16 April 2020
  • 248
Bioresearch Monitoring (BIMO) Fiscal Year 2019 Metrics
On 8 April 2020 the FDA published the bioresearch monitoring inspection metrics for the fiscal year 2019.
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  • 16 April 2020
  • 252
Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
On 9 April 2020 the UK MHRA published the guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home.
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  • 16 April 2020
  • 309
Guidance on regulatory requirements in the context of the COVID-19 pandemic
On 10 April the European Commission, EMA and the European medicines regulatory network have developed a Q&A document to provide guidance to stakeholders on
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  • 16 April 2020
  • 323
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
On 13 April 2020 the FDA announced the availability of this final guidance for industry.
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  • 16 April 2020
  • 292
Pharmacovigilance Inspection Metrics Report (April 2018 – March 2019)
On 15 April 2020 the UK MHRA published the annual report of pharmacovigilance inspection metrics from April 2018 till March 2019.
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  • 30 March 2020
  • 306
Medical Devices Clinical Investigations during the Coronavirus (COVID-19) outbreak
On 30 March 2020 the MHRA published the updated this guidance for investigators and sponsors of ongoing clinical investigations and new applications.
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  • 26 March 2020
  • 343
EMA EudraVigilance Registration Manual
On 26 March 2020 the EMA updated the EudraVigilance XCOMP (Test system) registration process.
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  • 24 March 2020
  • 344
Global Regulators Map out Data Requirements for Phase 1 COVID-19 Vaccine Trials
On 24 March 2020 the EMA announced that global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development.
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  • 20 March 2020
  • 616
EMA Management Board – highlights of March 2020 meeting
On 20 March 2020 the EMA highlighted the update on the development of the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation.
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  • 20 March 2020
  • 273
EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
On 20 March 2020 the EMA issued this guidance for industry, investigators and IRBs and on 27 March updated it.
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  • 20 March 2020
  • 248
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
On 20 March 2020 the FDA announced the availability of this final guidance for industry.
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  • 18 March 2020
  • 269
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
On 18 March 2020 the FDA issued this final guidance for industry, investigators and IRBs and on 27 March updated it.
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  • 18 March 2020
  • 266
Guidance on Paediatric Submissions
On 18 March 2020 the EMA issued the new guidance on eSubmission Gateway and eSubmission web client for paediatric investigation.
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  • 13 March 2020
  • 235
Competitive Generic Therapies
On 13 March 2020 the FDA announced the availability of the final guidance for industry.
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  • 12 March 2020
  • 261
510(k) Third Party Review Program
On 12 March 2020 the FDA issued the guidance for industry, FDA staff and third party review organizations.
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  • 10 March 2020
  • 246
Providing Regulatory Submissions in Alternate Electronic Format
On 10 March 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 11 May 2020.
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  • 10 March 2020
  • 232
GCP Inspections: Expectations and the dos and don’ts for hosting
On 10 March 2020 the MHRA posted the expectations of GCP inspections in the blog of the MHRA inspectorate.
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  • 10 March 2020
  • 254
Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections
On 10 March 2020 the FDA announced that the agency halts routine inspections overseas through April due to coronavirus.
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  • 10 March 2020
  • 357
China awards Gilead’s remdesivir patents, scolds local pharma over newsjacking
On 10 March 2020 GBI discussed China’s IP landscape and issues surrounding patent standards.
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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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