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  • 04 May 2021
  • 24
Draft Principles of ICH E6 Good Clinical Practice (GCP) now Available
On 19 April 2021 the ICH announced the availability of the draft principles of ICH E6 GCP.
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  • 04 May 2021
  • 20
CDISC CDASH SAE Supplement v2.0 Released
On 21 April 2021 the CDISC announced the release of the CDASH SAE Supplement version 2.0.
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  • 04 May 2021
  • 22
Request for Proposals for Auditors to Support Audits of MedDRA MSSO Operations
On 21 April 2021 the ICH launched a request for proposal for auditors in support of MedDRA MSSO audits.
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  • 04 May 2021
  • 39
Clinical Trials Information System Reaches Major Milestone towards Go-Live and Application of the Clinical Trial Regulation
On 21 April 2021 the EMA announced that the CTIS is on track to go live with the application of Clinical Trial Regulation.
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  • 04 May 2021
  • 27
Questions and Answers on the Principles of GMP for the Manufacturing of Starting Materials of Biological Origin Used to Transfer Genetic Material for the Manufacturing of ATMPs
On 23 April 2021 the EMA announced the availability of the updated Q&A guidance on GMP.
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  • 04 May 2021
  • 27
The ICH Q3C(R8) Guideline Reaches Step 4 of the ICH Process
On 23 April 2021 the ICH announced the status of the maintenance process for the ICHQ3C(R8) guideline.
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  • 04 May 2021
  • 29
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases
On 26 April 2021 the FDA published draft guidance for sponsor-investigators.
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  • 04 May 2021
  • 103
Public Web Conference Organised by the ICH E6(R3) EWG
On 26 April 2021 the ICH announced a free public web conference held by the ICH E6(R3) GCP EWG on 18-19 May 2021.
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  • 04 May 2021
  • 30
A New Collaboration between SNOMED International and ICH Promotes Seamless Data Exchange in Support of Public Health
On 29 April 2021 the ICH announced a new collaboration between SNOMED International and ICH.
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  • 19 April 2021
  • 57
Clinical Trials Guidance on Notification of Serious Breach
On 1 March 2021 Singapore’s Health Sciences Authority (HSA) published the clinical trials guidance on notification of serious breach.
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  • 19 April 2021
  • 58
Development of Abbreviated New Drug Applications (ANDAs) During the COVID-19 Pandemic – Questions and Answers
On 5 April 2021 the FDA issued the final Q&A guidance on ANDAs development during COVID-19.
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  • 19 April 2021
  • 87
Risk Management Information Day 2021
On 9 April 2021 the EMA announced a virtual event about risk management information will be held on 15 June 2021.
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  • 19 April 2021
  • 58
Overview of Comments Received on 'ICH Reflection Paper on Proposed ICH Guideline Work to Advance Patient Focused Drug Development’
On 14 April 2021 the EMA announced the availability of the overview of comments.
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  • 19 April 2021
  • 55
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency — Guidance for Industry
On 14 April 2021 the FDA issued the final guidance on remote evaluations of drug manufacturing and bioresearch monitoring facilities during COVID-19.
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  • 19 April 2021
  • 134
Updated IRIS Guide to Registration
On 15 April 2021 the EMA announced the availability of the updated IRIS guide on preliminary requirements for all IRIS submissions, including substance and research product identifier registration (version 2.6).
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  • 01 April 2021
  • 240
MHRA Updated Guidance on Managing Clinical Trials During Coronavirus (COVID-19)
On 16 March 2021 the UK MHRA updated the guidance on managing clinical trials during COVID-19.
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  • 01 April 2021
  • 237
EMA Updated the Pharmacovigilance System Manual
On 16 March 2021 the EMA updated the pharmacovigilance system manual version 1.3.
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  • 01 April 2021
  • 281
EMA Updated the Clinical Trials Information System’s Training Programme
On 16 March 2021 the EMA announced the updates of the clinical trials information system’s training programme.
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  • 01 April 2021
  • 221
Biocompatibility Assessment Resource Center
On 18 March 2021 the FDA launched a biocompatibility assessment resource center for medical devices.
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  • 01 April 2021
  • 244
FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic
On 18 March 2021 the FDA published insights from its leadership and experts into the FDA’s approach to foreign and domestic inspections.
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  • 01 April 2021
  • 257
Guidance for Industry on MHRA’s Expectations for Return to UK On-site Inspections
On 19 March 2021 the guidance was updated on the MHRA UK risk-based GxP inspection programme.
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  • 01 April 2021
  • 244
Inclusion/Exclusion Criteria for the “Important Medical Events” List
On 24 March 2021 the EMA announced the availability of the updated guidance related to the current version of MedDRA.
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  • 01 April 2021
  • 175
Inspectors Grounded – A Year of Innovation
On 26 March 2021 the MHRA inspectorate shared the past year’s inspection experience and the future of innovative inspections.
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  • 01 April 2021
  • 103
Generic Drugs Forum 2021: Lifecycle of a Generic Drug
On 30 March 2021 the FDA announced the Generic Drugs Forum webinar scheduled for 28-29 April 2021.
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  • 01 April 2021
  • 89
MHRA Guidance on Responding to a GLP & GCP Laboratories Inspection Report
On 30 March 2021 the UK MHRA published the guidance for industry on preparing responses to GLP and GCP inspection reports.
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  • 26 March 2021
  • 29
WS Presenting at Swiss Chinese Chamber of Commerce on 30 March 2021
Michael Zang, WSQMS Regulatory Affairs /Global Life Science Consultant, will be presenting at the Swiss Chinese Chamber of Commerce (SCCC) on March 30 2021.

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  • 16 March 2021
  • 187
Notify the MHRA about a Clinical Investigation for a Medical Device
On 3 March 2021 the MHRA updated the guidance on how to notify the MHRA of a clinical investigation for a medical device.
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  • 16 March 2021
  • 228
COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers
On 4 March 2021 the FDA published the final guidance for industry.
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  • 16 March 2021
  • 155
Pilot project ‘Market Launch Intentions of Centrally Authorized Products’
On 5 March 2021 the EMA published the guidance on the practical questions and answers about the pilot project.
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  • 16 March 2021
  • 168
Workshop on the General Data Protection Regulation (GDPR) and Secondary Use of Data for Medicines and Public Health Purposes
On 5 March 2021 the EMA published the presentation materials from the workshop held on 29 September 2020.
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  • 16 March 2021
  • 204
Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland/Northern Ireland
On 5 March 2021 the EMA issued additional practical Q&A guidance on the applicable rules in Northern Ireland after the transition period with respect to EMA activities and medicinal products for human and veterinary use within the framework of the centralized procedure.
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  • 16 March 2021
  • 271
Register Medical Devices to Place on the Market
On 12 March 2021 the MHRA updated the guidance on how to register medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
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  • 16 March 2021
  • 181
EMA Updated Clinical Trials Information System Development
On 12 March 2021 the EMA announced updated information on the clinical trials information system (CTIS).
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  • 16 March 2021
  • 137
Labelling Flexibilities for COVID-19 Therapeutics
On 12 March 2021 the EMA announced the availability of guidance on labelling flexibilities for COVID-19 treatments.
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  • 03 March 2021
  • 164
EMA Updated Q&A: Good Clinical Practice
On 16 February 2021 the EMA updated GCP Q&A by adding a new Q&A (#15) to the GCP Matters section.
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  • 03 March 2021
  • 246
Audit Checklist – Interpretation Guide
On 16 February 2021 the EMA published the first interpretation guide to support the common audit checklist, in cooperation with the members of the joint audit programme.
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  • 03 March 2021
  • 173
MHRA Updated Guidance on Managing Clinical Trials during COVID-19
On 17 February 2021 the MHRA updated the guidance by adding a section on the management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials.
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  • 03 March 2021
  • 141
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests
On 22 February 2021 the FDA issued initial guidance for test developers and FDA staff.
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  • 03 March 2021
  • 129
Emergency Use Authorization for Vaccines to Prevent COVID-19
On 22 February 2021 the FDA issued additional guidance for industry.
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  • 03 March 2021
  • 143
Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management services: Chapter 8 – Practical examples.
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  • 03 March 2021
  • 187
Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe: Chapter 3
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management service: Chapter 3 – Process for the electronic submission of medicinal products information.
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  • 03 March 2021
  • 182
Clinical Trials Regulation (EU) No 536/2014: Questions & Answers
On 24 February 2021 the European Commission released the draft Q&A on EU clinical trials regulation No 536/2014, version 3.
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  • 03 March 2021
  • 153
MHRA Pharmacovigilance Inspection Metrics: April 2019 to March 2020
On 26 February 2021 the MHRA GPvP inspectorate published the latest inspection metrics for the period from April 2019 to March 2020.
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  • 17 February 2021
  • 6038
Chinese NMPA Released the National Medical Products Newsletter
In January 2021 the Chinese NMPA published 2021 Volume I of the National Medical Products Newsletter.
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  • 17 February 2021
  • 213
Draft Toolbox Guidance on Scientific Elements and Regulatory Tools to Support Quality Data Packages for PRIME Marketing Authorization Applications
On 2 February 2021 the EMA published the draft toolbox guidance. Comments should be submitted by 31 July 2021.
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  • 17 February 2021
  • 272
EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI Addendum II
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI Addendum II – Methods for Effectiveness Evaluation. Comments should be submitted by 28 April 2021.
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  • 17 February 2021
  • 210
EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI – Risk Minimization Measures: Selection of Tools and Effectiveness Indicators (Rev 3). Comments should be submitted by 28 April 2021.
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  • 17 February 2021
  • 228
Guidance on the Management of Clinical Trials During the Covid-19 (Coronavirus) Pandemic
On 4 February 2021 the EMA published guidance version 4 with the key changes of remote source data verification.
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  • 17 February 2021
  • 298
Reference Safety Information (RSI) for Clinical Trials – Part III
On 5 February 2021 the MHRA GCP inspectorate published the RSI blog posts Part III.
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  • 17 February 2021
  • 219
EMA Post-authorization Procedural Advice for Users of the Centralized Procedure
On 8 February 2021 the EMA published the post-authorization guidance.
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  • 17 February 2021
  • 172
Investigational COVID-19 Convalescent Plasma
On 11 February 2021 the FDA published revised guidance for industry.
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  • 17 February 2021
  • 201
MHRA Guidance on Pharmacovigilance Requirements for UK Authorized Products from 1 January 2021
On 12 February 2021 the guidance was published on the MHRA inspectorate blog.
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  • 17 February 2021
  • 178
GCP Inspections Metrics Report
On 12 February 2021 the MHRA GCP Inspectorate issued the GCP inspections metrics report covering 1 April 2018 to 31 March 2019.
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  • 02 February 2021
  • 208
FDA Released Artificial Intelligence/Machine Learning Action Plan
On 12 January 2021 the FDA released the agency’s first artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan.
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  • 02 February 2021
  • 228
Guidelines 01/2021on Examples Regarding Data Breach Notification
On 18 January 2021 the European Data Protection Board announced the notification for public consultation. Comments should be sent by 2 March 2021.
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  • 02 February 2021
  • 32776
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
On 19 January 2021 the FDA published the final guidance for industry.
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  • 02 February 2021
  • 236
Commission Notice – Application of the Union’s Pharmaceutical Acquis in Markets Historically Dependent on Medicines Supply from or through Great Britain after the End of the Transition Period
On 25 January 2021 the EMA published the European Commission notice to stakeholders.
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  • 02 February 2021
  • 232
Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe
On 25 January 2021 the European Network of Paediatric Research at the EMA’s (Enpr-EMA’s) Working Group on Ethics developed the guidance.
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  • 02 February 2021
  • 222
FDA Updated Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 27 January 2021 the FDA updated the final guidance for industry, investigators and institutional review boards.
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  • 02 February 2021
  • 207
Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 28 January 2021 the FDA published the final guidance for industry and FDA staff.
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  • 02 February 2021
  • 194
Overview of Comments Received on 'Draft Questions and Answers on Data Monitoring Committees Issues' (EMA/492010/2018)
On 29 January 2021 the EMA published the overview of comments on draft Q&A on Data Monitoring Committees Issues.
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  • 19 January 2021
  • 253
IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations
On 4 January 2021 the FDA announced the availability of the draft guidance for sponsor-investigators. Comments may be submitted until 4 March 2021.
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  • 19 January 2021
  • 234
Human Gene Therapy for Neurodegenerative Diseases
On 5 January 2021 the FDA announced the availability of the draft guidance for industry.
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  • 19 January 2021
  • 252
Safer Technologies Program for Medical Devices
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 19 January 2021
  • 393
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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  • 19 January 2021
  • 228
Florida Medical Doctor Pleads Guilty to Conspiring to Falsify Clinical Trial Data
On 8 January 2021 the FDA released press on a sentence of medical doctor falsifying clinical trial data.
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  • 19 January 2021
  • 232
COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
On 13 January 2021 the FDA published the guidance.
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  • 19 January 2021
  • 220
EMA Procedural Advice for Users of the Centralized Procedure
On 13 January 2021 the EMA updated 3 guidance on pre-/post-authorization procedural advice for users of the centralized procedure or for generic/hybrid applications.
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  • 19 January 2021
  • 195
EMA Updated Guidance on Obtaining and Maintaining a Scientific Opinion on a Medicine for Use Outside the EU
On 14 January 2021 the EMA updated the guidance on promoting parallel application for EU-M4all opinion and centralized marketing authorization procedure.
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  • 19 January 2021
  • 194
EMA Updated Questions & Answers on Signal Management
On 15 January 2021 the EMA published revision 4 of the Q&A on signal management.
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  • 19 January 2021
  • 194
Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
On 15 January 2021 the FDA published the final guidance for industry.
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  • 05 January 2021
  • 315
EMA Updated Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers
On 16 December 2020 the EMA updated Q&A guidance on GMP and GDP in EU GMP guide part I, chapter 5.
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  • 05 January 2021
  • 249
EMA Updated Questions and Answers on Labeling Flexibilities for COVID-19 Vaccines
On 16 December 2020 the EMA published the revision 1 of Q&A document on labelling flexibilities for COVID-19 vaccines.
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  • 05 January 2021
  • 346
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
On 16 December 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 January 2021
  • 245
ontrolled Correspondence Related to Generic Drug Development Guidance for Industry
On 16 December 2020 the FDA published the final guidance for industry.
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  • 05 January 2021
  • 246
Dry Eye: Developing Drugs for Treatment
On 16 December 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 17 March 2021.
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  • 05 January 2021
  • 246
EMA Updated IRIS Guide for Applicants
On 17 December 2020 the EMA published the updated version 1.9 of IRIS guide for industry and individual applicants.
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  • 05 January 2021
  • 241
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion
On 17 December 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 January 2021
  • 320
EMA Updated Clinical Trials Information System Development
On 18 December 2020 the EMA published the updated clinical trials information system (CTIS) development.
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  • 05 January 2021
  • 237
Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 21 December 2020 the EMA published the guidance for sponsors.
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  • 05 January 2021
  • 221
Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency — Guidance for Industry
On 21 December 2020 the FDA announced the availability of the final guidance for industry.
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  • 05 January 2021
  • 219
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised)
On 22 December 2020 the FDA published the updated Q&A guidance for industry and FDA staff.
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  • 05 January 2021
  • 201
Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
On 23 December 2020 the FDA published the final guidance for industry.
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  • 05 January 2021
  • 172
MHRA Guidance on Submitting Clinical Trial Safety Reports
On 31 December 2020 the MHRA published the guidance on how to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs).
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  • 05 January 2021
  • 267
Exceptions and Modifications to the EU Guidance on Good Pharmacovigilance Practices that Apply to UK Marketing Authorization Holders and the Licensing Authority
On 31 December 2020 the MHRA published a guidance note on GVP.
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  • 05 January 2021
  • 185
MHRA Guidance on Substantial Amendments to a Clinical Trial
On 31 December 2020 the MHRA published guidance on substantial amendments to a clinical trial.
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  • 17 December 2020
  • 398
Requesting FDA Feedback on Combination Products
On 3 December 2020 the FDA Announced the Availability of the Final Guidance for Industry and FDA Staff.
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  • 17 December 2020
  • 279
Update to FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency
On 4 December 2020 the FDA Updated the Final Guidance for Industry, Investigators, and Institutional Review Boards.
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  • 17 December 2020
  • 332
Reflection Paper on Patient-Focused Drug Development for Public Consultation
On 7 December 2020 the ICH Published the Reflection Paper on PFDD for Public Consultation by 7 March 2021.
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  • 17 December 2020
  • 324
MHRA Updated Guidance on Regulating Medical Devices from 1 January 2021
On 7 December 2020 the MHRA Updated the Medical Devices Guidance.
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  • 17 December 2020
  • 311
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry
On 8 December 2020 the FDA Announced the Availability of the Draft Guidance for Industry.
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  • 17 December 2020
  • 319
European Medicines Agencies Network Strategy to 2025
On 8 December 2020 the EMA Published the Joint Strategy Setting Direction for EMA and EU Medicines Regulatory Agencies to 2025.
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  • 17 December 2020
  • 330
The eCTD v4.0 Q&A v1.4 Reaches Step 4 of the ICH Process
On 9 December 2020 the ICH Announced eCTD v4.0 Reaches Step 4.
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  • 17 December 2020
  • 367
Clinical Trials Information System (CTIS) Highlights – December 2020
On 9 December 2020 the EMA Published Issue 2 of CTIS Highlights.
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  • 17 December 2020
  • 251
Best Practices in Developing Proprietary Names for Human Prescription Drug Products
On 9 December 2020 the FDA Announced the Availability of the Final Guidance for Industry.
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  • 17 December 2020
  • 242
Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway
On 11 December 2020 the FDA Issued the Final Guidance for Industry and FDA Staff.
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  • 17 December 2020
  • 248
Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland / Northern Ireland
On 11 December 2020 the EMA Published Revision 2 of the Q&A Document.
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  • 01 December 2020
  • 302
Remote Pharmacovigilance Inspections of MAHs during a Crisis Situation - Points to Consider
On 18 November 2020 the EMA announced the availability of revision 1 of the guidance adopted by Pharmacovigilance Inspectors Working Group.
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  • 01 December 2020
  • 306
Clinical Drug Interaction Studies with Combined Oral Contraceptives
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 22 February 2021.
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  • 01 December 2020
  • 314
Cross Labeling Oncology Drugs in Combination Regimens
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.
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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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