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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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  • 21 October 2022
  • 174
ANDA Submissions – Prior Approval Supplements Under GDUFA
14 October 2022 — FDA published final guidance on ADNA submissions for industry.
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  • 21 October 2022
  • 171
IRIS Guide for Parallel Distribution Applicants
3 October 2022 — EMA published the updated IRIS guide for parallel distribution applicants.
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  • 21 October 2022
  • 326
Presentation – Clinical Trials Information System (CTIS) Bitesize Talk (Notifications - Part 1)
3 October 2022 — EMA published part 1 of the recent CTIS bitesize talk presentation.
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  • 21 October 2022
  • 165
FAQs: How to Evaluate a CTA – CTIS Training Program Module 06
5 October 2022 — EMA published version 1.4 FAQs on how to evaluate a CTA.
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  • 21 October 2022
  • 172
Reflection Paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials, with Particular Emphasis on the Handling of Expiry Dates
5 October 2022 — EMA published the updated reflection paper on the use of IRT.
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  • 21 October 2022
  • 175
ICH Guideline S1B(R1) on Testing for Carcinogenicity of Pharmaceuticals
10 October 2022 — EMA published the ICH guideline S1B1(R1) – Step 5.
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  • 21 October 2022
  • 261
Data Quality Framework for EU Medicines Regulation
10 October 2022 — EMA published the draft data quality framework for the public consultation until 18 November 2022.
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  • 21 October 2022
  • 171
Updated Q&A: Good Clinical Practice (GCP)
10 October 2022 — EMA published updated Q&A guidance on GCP.
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  • 21 October 2022
  • 180
IRIS Guide for Applicants
10 October 2022 — EMA published version 2.13 of the IRIS guide for applicants.
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  • 21 October 2022
  • 218
EMA Account Management Training Session Presentation
11 October 2022 — EMA published the presentation shown at the account management training session.
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  • 21 October 2022
  • 188
EMA IRIS Industry Training for GVP Inspections: Questions & Answers
11 October 2022 — EMA published the Q&A guidance on IRIS industry training for GVP inspections.
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  • 21 October 2022
  • 190
Digital Application Dataset Integration (DADI) eAF Training Webinars (26 July 2022 & 2 September 2022): Questions and Answers
12 October 2022 — EMA published the Q&A guidance on the recent DADI eAF webinars
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  • 21 October 2022
  • 238
European Medicines Agency Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
14 October 2022 — EMA published rev. 14 guidance for applicants seeking scientific advice and protocol assistance.
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  • 04 October 2022
  • 249
Questions and Answers on Labeling Flexibilities for COVID-19 Vaccines
On 16 September 2022 the EMA published the Q&A guidance on labeling flexibilities for COVID-19 vaccines.
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  • 04 October 2022
  • 204
Concept Paper on the Establishment of a Guideline on the Development and Manufacture of Synthetic Oligonucleotides
On 16 September 2022 the EMA published the draft guidance for consultation from 20 September 2022 to 20 December 2022.
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  • 04 October 2022
  • 191
The Northern Ireland MHRA Authorized Route (NIMAR)
On 20 September 2022 the MHRA published the updated NIMAR guidance.
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  • 04 October 2022
  • 287
Notify the MHRA about a Clinical Investigation for a Medical Device
On 21 September 2022 the MHRA published the updated guidance on notification of clinical investigation for medical devices.
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  • 04 October 2022
  • 195
How to Obtain a Covered Product Authorization
On 21 September 2022 the FDA published the draft guidance for industry. Submit comments by 21 November 2022.
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  • 04 October 2022
  • 192
Electronic Submission Template for Medical Device 510(k) Submissions
On 22 September 2022 the FDA published the final guidance for industry and FDA staff.
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  • 04 October 2022
  • 290
IRIS Guide for Applicants
On 23 September 2022 the EMA published version 2.12 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
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  • 04 October 2022
  • 188
FAQs: How to Create, Submit and Withdraw a Clinical Trial Application — CTIS Training Program - Module 10
On 23 September 2022 the EMA published version 1.3 of the updated FAQs guidance on how to create, submit and withdraw a clinical trial application.
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  • 04 October 2022
  • 196
Ethical Considerations for Clinical Investigations of Medical Products Involving Children
On 26 September 2022 the FDA published the draft guidance for industry, sponsors and IRBs.
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  • 04 October 2022
  • 193
Update - EudraLex - Volume 10 - Clinical trials guidelines - Questions and Answers Document - Regulation (EU) 536/2014 – Version 6.2 (September 2022)
On 26 September 2022 the European Commission published the updated Q&A document on clinical trials regulation EU 536/2014, version 6.2.
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  • 04 October 2022
  • 187
Good Clinical Practice for Clinical Trials
On 27 September 2022 the MHRA published the updated guidance on GCP for clinical trials.
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  • 04 October 2022
  • 279
Providing Over-the-Counter Monograph Submissions in Electronic Format
On 27 September 2022 the FDA published the draft guidance. Submit comments by 28 November 2022.
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  • 04 October 2022
  • 181
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
On 27 September 2022 the FDA published updated guidance for developers and FDA staff.
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  • 04 October 2022
  • 371
Checking Process of Mock-Ups and Specimens of Outer/Immediate Labeling and Package Leaflets of Human Medicinal Products in the Centralized Procedure
On 28 September 2022 the EMA published the guidance on checking process of mock-ups and specimens.
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  • 04 October 2022
  • 177
Policy for Device Software Functions and Mobile Medical Applications
On 28 September 2022 the FDA published the final guidance on the regulatory oversight to certain software for industry and FDA staff.
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  • 04 October 2022
  • 338
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
On 28 September 2022 the FDA published the final guidance on regulatory oversight to certain medical devices for industry and FDA staff.
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  • 04 October 2022
  • 183
Display Devices for Diagnostic Radiology
On 28 September 2022 the FDA published the final guidance on premarket notification submissions for display devices for industry and FDA staff.
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  • 04 October 2022
  • 146
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
On 28 September 2022 the FDA published the final guidance on premarket notification submissions for computer-assisted detection devices for industry and FDA staff.
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  • 04 October 2022
  • 179
Clinical Decision Support Software
On 28 September 2022 the FDA published the final guidance on the scope of oversight of clinical decision support software.
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  • 04 October 2022
  • 178
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
On 28 September 2022 the FDA published final guidance for industry and FDA staff.
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  • 04 October 2022
  • 171
Procedural Advice for Post-Orphan Medicinal Product Designation Activities
On 30 September 2022 the EMA published revision 13 on guidance for post-orphan designated products for sponsors.
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  • 21 September 2022
  • 236
Manual on Borderline and Classification for Medical Devices under Regulation (EU)
In September 2022 the European Commission published version 1 of the manual on borderline and classification for medical devices.
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  • 21 September 2022
  • 214
Accelerating Clinical Trials in the EU (ACT EU) Multi-Annual Workplan 2022-2026
On 2 September the EMA published the updated ACT EU multi-annual workplan.
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  • 21 September 2022
  • 242
Swissmedic Online Information Event: New Regulations on In Vitro Diagnostic Medical Devices
On 5 September Swissmedic announced an online information event for new regulations on in vitro diagnostic medical devices.
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  • 21 September 2022
  • 189
Updated IRIS Guide for Applicants
On 5 September the EMA published version 2.12 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
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  • 21 September 2022
  • 202
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products
On 7 September 2022 the FDA published draft guidance on clinical pharmacology considerations for pediatric studies.
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  • 21 September 2022
  • 195
EMA IRIS Industry Training for GVP Inspections
On 8 September the EMA published their online training sessions of IRIS for GCP inspections.
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  • 21 September 2022
  • 192
Medical Devices: Software Applications (Apps)
On 8 September 2022 the MHRA published updated guidance on software apps as medical devices.
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  • 21 September 2022
  • 194
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
On 8 September 2022 the FDA published the final guidance on real-world data and real-world evidence.
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  • 21 September 2022
  • 228
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products
On 8 September 2022 the FDA published the draft guidance on quantitative labeling. Submit comments by 8 November 2022.
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  • 21 September 2022
  • 177
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products
On 8 September 2022 the FDA published draft guidance on content and format of labeling for human nonprescription drug products. Submit comments by 8 November 2022.
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  • 21 September 2022
  • 180
Certificates of Free Sale to Danish Manufacturers of Medical Devices
On 12 September 2022 the Danish Medicines Agency updated the medical devices guidance on certificates of free sale.
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  • 21 September 2022
  • 178
Policy for Monkeypox Tests to Address the Public Health Emergency
On 13 September 2022 the FDA published final guidance on monkeypox tests for laboratories, commercial manufacturers and FDA staff.
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  • 21 September 2022
  • 176
Computer Software Assurance for Production and Quality System Software
On 13 September 2022 the FDA published draft guidance on computer software assurance for industry and FDA staff. Submit comments by 14 November 2022.
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  • 21 September 2022
  • 199
Q3D(R2) – Guideline for Elemental Impurities
On 14 September 2022 the FDA published draft guidance on elemental impurities.
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  • 05 September 2022
  • 222
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
On 17 August 2022 FDA issued final guidance for industry and FDA staff.
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  • 05 September 2022
  • 249
A Regulatory Pharmaceutical Quality Knowledge Management System (PQKMS) to Enhance the Availability of Quality Medicines
On 17 August 2022 ICMRA (International Coalition of Medicines Regulatory Authorities) published a joint reflection paper in support of the regulatory PQ KMS.
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  • 05 September 2022
  • 236
Charging for Investigational Drugs Under an IND – Questions and Answers
On 23 August 2022 FDA published revised draft Q&A guidance. Submit comments by 24 October 2022.
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  • 05 September 2022
  • 318
Information Event “Regulatory & Beyond”
On 22 August 2022 Swissmedic announced a hybrid information event “Regulatory & Beyond” to be held on 20 September 2022 in Bern.
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  • 05 September 2022
  • 236
Innovation, Quality & Transparency – a Compliance Team 1 Perspective
On 23 August 2022 UK MHRA Inspectorate published a blog on Compliance Matters.
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  • 05 September 2022
  • 230
EMA EudraVigilance Registration Manual
On 23 August 2022 EMA published the updated EudraVigilance registration manual.
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  • 05 September 2022
  • 234
Sponsors’ Guide: Transitional Trials from EudraCT to CTIS (sponsor users)
On 24 August 2022 EMA published the CTIS training program, module 23, version 1.2.
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  • 05 September 2022
  • 223
FAQs: Transitional Trials from EudraCT to CTIS
On 24 August 2022 EMA published the CTIS training program, module 23, version 1.2.
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  • 05 September 2022
  • 228
Revision – Manufacture of Sterile Medicinal Products
On 25 August 2022 the European Commission published the revised guideline for GMP in the EudraLex Volume 4, annex 1.
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  • 05 September 2022
  • 222
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential – Questions and Answers
On 26 August 2022 the FDA published final Q&A guidance on ICH E14 and S7B.
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  • 05 September 2022
  • 295
Q2(R2) Validation of Analytical Procedures
On 26 August 2022 the FDA published draft guidance on ICH Q2(R2).
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  • 05 September 2022
  • 220
Q14 Analytical Procedure Development
On 26 August 2022 the FDA published draft guidance on ICH Q14.
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  • 05 September 2022
  • 235
M12 Drug Interaction Studies
On 26 August 2022 the FDA published draft guidance on ICH M12.
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  • 05 September 2022
  • 231
E11A Pediatric Extrapolation
On 26 August 2022 the FDA published draft guidance on ICH E11A.
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  • 05 September 2022
  • 233
Guidance for Applicants/MAHs Involved in GMP, GCP and GVP Inspections Coordinated by EMA
On 31 August 2022 the EMA published guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA, version 3.0.
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  • 26 August 2022
  • 338
Changes to Guidance Document Authorization Procedures for COVID-19 Medicinal Products During a Pandemic HMV4
1 August 2022 — Swissmedic published the revised guidance document effective 1 August 2022.
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  • 26 August 2022
  • 269
Digital Application Dataset Integration (DADI) Q&A Webinar - Variations Form for Human Medicinal Products
2 August 2022 — EMA published the DADI Q&A webinar summary document.
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  • 26 August 2022
  • 283
News Bulletin for Small and Medium-Sized Enterprises (SME)
2 August 2022 — EMA published Issue 56 of the SME Office Newsletter.
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  • 26 August 2022
  • 241
Application for Priority Applicant Determination - Medical Devices
2 August 2022 — Australian Therapeutic Goods Administration (TGA) announced the availability of the application form for priority applicant determination of medical devices.
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  • 26 August 2022
  • 252
Version 2.8 of Technical Documentation - UDI/Devices Registration
2 August 2022 — European Commission published the technical documentation version 2.8 for unique device identifier (UDI)/Devices registration.
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  • 26 August 2022
  • 218
Clinical Trials for Medicines: Manage Your Authorization, Report Safety Issues
2 August 2022 — MHRA updated the guidance on clinical trials for medicines.
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  • 26 August 2022
  • 238
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies
2 August 2022 — FDA published draft guidance for industry. Submit comments by 3 October 2022.
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  • 26 August 2022
  • 240
EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines
3 August 2022 — EMA published guidance on rapid formal review procedures related to COVID-19.
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  • 26 August 2022
  • 248
Decommission of eSUSAR
3 August 2022 — MHRA inspectorate announced decommission of eSUSAR.
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  • 26 August 2022
  • 259
Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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  • 26 August 2022
  • 272
Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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  • 26 August 2022
  • 261
IRIS for Good Pharmacovigilance Practice (GVP) Inspections Training Session for Industry Users
9 August 2022 — EMA announced the GVP inspections training session on 7 September 2022.
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  • 26 August 2022
  • 244
EVVet3 Production - Release Notes
8 August 2022 — EMA published v1.6 release notes of EVVet3.
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  • 26 August 2022
  • 239
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
15 August 2022 — FDA published the technical specifications document of the final E2B(R3) guidance for industry.
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  • 26 August 2022
  • 264
Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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  • 26 August 2022
  • 263
Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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  • 26 August 2022
  • 224
IRIS for Good Pharmacovigilance Practice (GVP) Inspections Training Session for Industry Users
9 August 2022 — EMA announced the GVP inspections training session on 7 September 2022.
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  • 26 August 2022
  • 247
EVVet3 Production – Release Notes
8 August 2022 — EMA published v1.6 release notes of EVVet3.
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  • 26 August 2022
  • 218
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
15 August 2022 — FDA published the technical specifications document of the final E2B(R3) guidance for industry.
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  • 21 August 2022
  • 236
Clinical Trials for Medicines: Apply for Authorization in the UK
On 18 July 2022 the MHRA updated the guidance on clinical trials for medicines.
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  • 21 August 2022
  • 243
Evaluation of Therapeutic Equivalence
On 21July 2022 the FDA published the draft guidance on evaluation of therapeutic equivalence of generic drugs. Submit comments by 19 September 2022.
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  • 21 August 2022
  • 242
Good Laboratory Practice (GLP) for Safety Tests on Chemicals
On 21 July 2022 the MHRA updated the guidance on GLP
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  • 21 August 2022
  • 257
ICH Guideline M12 on Drug Interaction Studies
On 21 July 2022 the EMA published the draft ICH guideline M12, step 2b.
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  • 21 August 2022
  • 258
Global Regulators Call for International Collaboration to Integrate Real-World Evidence into Regulatory Decision-Making
On 22 July 2022 the EMA announced the availably of a joint ICMRA statement on international collaboration to enable RWE for regulatory decision-making.
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  • 21 August 2022
  • 243
Real-Time Oncology Review (RTOR)
On 22 July 2022 the FDA published the draft guidance on real-time oncology review for industry. Submit comments by 20 September 2022.
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  • 21 August 2022
  • 279
Conducting Remote Regulatory Assessments Questions and Answers
On 22 July 2022 the FDA published the draft Q&A guidance on conducting remote regulatory assessments for industry.
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  • 21 August 2022
  • 262
Failure to Respond to an Abbreviated New Drug Applications (ANDA) Complete Response Letter (CRLs) within the Regulatory Timeframe
On 22 July 2022 the FDA published the final guidance on responding to complete response letters (CRLs) from FDA for industry.
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  • 21 August 2022
  • 290
Orange Book Questions and Answers Guidance for Industry
On 22 July 2022 the FDA published the final orange book Q&A guidance for industry.
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  • 21 August 2022
  • 228
Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices
On 22 July 2022 the FDA published the final UDI guidance for industry and FDA staff.
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  • 21 August 2022
  • 272
Clinical Trials Highlights - July 2022
On 25 July 2022 the EMA published the Clinical Trials Highlights, issue 10.
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  • 21 August 2022
  • 307
ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis
On 27 July 2022 the EMA published the ICH guideline M10, step 5.
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  • 21 August 2022
  • 322
ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis – Frequently Asked Questions (FAQ)
On 27 July 2022 the EMA published the FAQ on ICH guideline M10, step 5.
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  • 21 August 2022
  • 286
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
On 27 July 2022 the FDA published the final guidance on general clinical pharmacology considerations for neonatal studies
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  • 21 August 2022
  • 202
Laser-Assisted in Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations
On 28 July 2022 the FDA published the draft guidance on patient labeling recommendations for LASIK lasers for industry and FDA staff. Submit comments by 26 October 2022.
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  • 21 August 2022
  • 360
Qualification Opinion of the Use of Enroll-HD (A Huntington’s Disease Patient Registry) as a Data Source and Infrastructure Support for Post-Authorization Monitoring of Medical Products
On 28 July 2022 the EMA published the qualification opinion on the use of Enroll-HD as a data source and infrastructure support for post-authorization monitoring of medical products.
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  • 21 August 2022
  • 262
Register Medical Devices to Place on the Market
On 28 July 2022 the MHRA updated the guidance on registration of medical devices.
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  • 21 August 2022
  • 334
PMDA Guidance on Risk Management Plan (RMP)
On 29 July 2022 the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) posted RMP page renewal, Q&A, templates, instructions and publication.
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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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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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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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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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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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