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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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  • 18 May 2023
  • 71
Modification of the Drug Master File (DMF) Form
1 May 2023 – the Swissmedic published the modified DMF form.
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  • 18 May 2023
  • 59
Changes to the Forms for New Authorizations of and Variations to Human and Veterinary Medicinal Products
1 May 2023 – the Swissmedic published information on study design and data sources of RWE in application forms.
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  • 18 May 2023
  • 53
Changes to the Guidance Document GMP Compliance by Foreign Manufacturers and the Form Declaration by the Responsible Person for Foreign Manufacturers
1 May 2023 – the Swissmedic published updated guidance documents on clarification of the requirements for the submission of audit reports.
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  • 18 May 2023
  • 53
Medical Devices Swissmedic Hospital Inspections 2021/2022 Annual Report
12 May 2023 – the Swissmedic published the 2021/2022 annual report of the Swissmedic Hospital Inspections on Medical Devices.
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  • 18 May 2023
  • 55
ICH E6(R3) Good Clinical Practice Guidance – Step 2 Public Consultation
2 May 2023 – the UK MHRA Inspectorate announced Step 2 – Public Consultation – of the ICH GCP guidance.
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  • 18 May 2023
  • 50
Notify the MHRA about a Clinical Investigation for a Medical Device
11 May 2023 – the UK MHRA published updated guidance on notifying the MHRA of a clinical investigation for a medical device.
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  • 18 May 2023
  • 53
Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF)
11 May 2023 – the UK MHRA published updated guidance on pharmacovigilance system requirements.
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  • 18 May 2023
  • 56
Register Medical Devices to Place on the Market
15 May 2023 – the UK MHRA published the updated guidance on registering medical devices to place on the market.
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  • 18 May 2023
  • 69
Reporting Adverse Incidents Involving Software as a Medical Device under the Vigilance System
15 May 2023 – the UK MHRA published guidance on reporting adverse incidents involving software as a medical device.
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  • 18 May 2023
  • 48
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products
1 May 2023 – the FDA published final guidance on developing nicotine replacement therapy drug products.
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  • 18 May 2023
  • 48
ICH S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
1 May 2023 – the FDA published the final ICH S12 guidance on nonclinical biodistribution (BD) studies for gene therapy (GT) products.
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  • 18 May 2023
  • 47
Study Data Technical Conformance Guide – Technical Specifications Document
1 May 2023 – the FDA published final guidance on the study data on technical conformance for the electronic submission.
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  • 18 May 2023
  • 44
Decentralized Clinical Trials for Drugs, Biological Products and Devices
3 May 2023 – the FDA published draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. Submit comments by 1 August 2023.
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  • 18 May 2023
  • 45
FDA Guidance on ICH Q9(R1) Quality Risk Management
3 May 2023 – the FDA published final guidance on the ICH Q9(R1) quality risk management.
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  • 18 May 2023
  • 42
Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
11 May 2023 – the FDA published final guidance on the recommendations for evaluating donor eligibility using individual risk-based questions.
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  • 18 May 2023
  • 64
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
11 May 2023 – the FDA published final guidance on implementing the full-length and abbreviated donor history questionnaires and accompanying materials.
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  • 18 May 2023
  • 42
Commission Guidance on the Content and Structure of the Summary of the Clinical Investigation Report
8 May 2023 – the Official Journal of the European Union published the summary document on the clinical investigation report for the medical device.
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  • 18 May 2023
  • 50
Interim Guidance Document on How to Approach the Protection of Personal Data and Commercially Confidential Information While Using the Clinical Trials Information System (CTIS)
3 May 2023 – the EMA published version 1.0 of the interim guidance on protecting personal data and confidential information while using the CTIS.
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  • 18 May 2023
  • 64
Concept Paper on Revision of the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Patients with Acute Respiratory Distress Syndrome (ARDS)
4 May 2023 – the EMA proposed guideline will replace the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome. Submit comments by 31 July 2023.
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  • 18 May 2023
  • 43
IRIS Guide to Registration and RPIs
12 May 2023 – the EMA published version 2.14 of the IRIS guide for all submissions, including substance and Research Product Identifier registration.
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  • 18 May 2023
  • 41
EMA Annual Report 2022
15 May 2023 – the EMA published its 2022 Annual Report.
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  • 18 May 2023
  • 67
Electronic Application Form (eAF) – Product Management Service (PMS) Newsletter
15 May 2023 – the EMA published Issue 3 of the eAF–PMS newsletter.
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  • 12 May 2023
  • 59
MORE Platform Application Programming Interface (API) Integration
24 April 2023 – the UK MHRA published the instructions and reference guides for integrating with the new production MORE platform API.
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  • 12 May 2023
  • 58
Swissmedic Becomes an Official Observer in the International Medical Devices Regulators Forum (IMDRF)
24 April 2023 – the Swissmedic announced the IMDRF granted the Swiss Agency for Therapeutic Products the status of Official Observer at Management Committee Meetings.
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  • 12 May 2023
  • 80
Register Medical Devices to Place on the Market
27 April 2023 – the UK MHRA published updated guidance on registration of medical devices to place on the market.
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  • 12 May 2023
  • 76
Implementation of the Future Regulations for Medical Devices
27 April 2023 – the UK MHRA published the updated guidance on the implementation of medical devices future regime.
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  • 12 May 2023
  • 49
Regulating Medical Devices in the UK
28 April 2023 – the UK MHRA published the updated guidance on regulating medical devices in the UK and EU markets.
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  • 12 May 2023
  • 61
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
19 April 2023 – the FDA published draft guidance on developing drugs for treating acute radiation syndrome. Submit comments by 19 July 2023.
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  • 12 May 2023
  • 51
Data Standards Catalog
28 April 2023 – the FDA published version 9.1 of the final updated guidance of the data standards catalog.
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  • 12 May 2023
  • 65
Frequently Asked Questions: Revision of the Pharmaceutical Legislation
26 April 2023 – the European Commission published Q&A guidance on the revision of the pharmaceutical legislation.
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  • 12 May 2023
  • 59
Frequently Asked Questions: Council Recommendation on Stepping up EU Actions to Combat AMR in a One Health Approach
26 April 2023 – the European Commission published the Q&A guidance on recommendation to combat antimicrobial resistance (AMR) in one health approach.
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  • 12 May 2023
  • 73
European Health Union: Commission Proposes Pharmaceuticals Reform for More Accessible, Affordable and Innovative Medicines
26 April 2023 – the European Commission proposes largest revision to pharmaceutical legislation in over 20 years.
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  • 12 May 2023
  • 51
ICH S12 Guideline on Nonclinical Biodistribution Considerations for Gene Therapy Products
20 April 2023 – the EMA published step 5 of the ICH S12 guideline.
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  • 12 May 2023
  • 45
IRIS Guide to Registration and RPIs
20 April 2023 – the EMA published version 2.14 on preliminary requirements for all IRIS submissions, including substance and Research Product Identifier (RPI) registration.
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  • 12 May 2023
  • 41
Reflection Paper on Establishing Efficacy Based on Single-Arm Trials (SATs) Submitted as Pivotal Evidence in a Marketing Authorization
21 April 2023 – the EMA published the draft reflection paper for consideration on evidence from single-arm trials.
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  • 12 May 2023
  • 67
EMA Pre-Authorization Guidance for Users of the Centralized Procedure
25 April 2023 – the EMA published the pre- / post-authorization guidance for users of the centralized procedure.
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  • 12 May 2023
  • 73
Clinical Data Publication
25 April 2023 – the EMA announced resumption of publishing clinical data submitted by pharmaceutical companies.
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  • 12 May 2023
  • 42
Biosimilar Medicines
26 April 2023 – the EMA published an updated statement and Q&A guidance on the scientific rationale supporting interchangeability of biosimilars medicines in the EU.
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  • 12 May 2023
  • 58
News Bulletin for Small and Medium-Sized Enterprises (SME)
28 April 2023 – the EMA published SME Newsletter – Issue 58.
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  • 12 May 2023
  • 50
Annual Report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2022
28 April 2023 – the EMA published revision 1 of the 2022 GMP/GDP IWG Annual Report.
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  • 20 April 2023
  • 86
The ICH M7(R2) Guideline Reaches Step 4 of the ICH Process
6 April 2023 – the ICH announced ICH M7(R2) guidelines reaches step 4.
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  • 20 April 2023
  • 95
Announcements on Clinical Trials with Medical Devices and Performance Studies with Vitro Diagnostic Medical Devices
13 April 2023 – the Swissmedic announced on submissions for combined trials with medical devices and vitro diagnostic medical devices.
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  • 20 April 2023
  • 155
How to Draft a Direct Healthcare Professional Communication
4 April 2023 – the UK MHRA published updated guidance for marketing authorization holders on drafting direct healthcare professional communications (DHPCs).
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  • 20 April 2023
  • 90
Software and Artificial Intelligence (AI) as a Medical Device
6 April 2023 – the UK MHRA published guidance on software and AI as a medical device.
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  • 20 April 2023
  • 119
Good Clinical Practice for Clinical Trials
6 April 2023 – the UK MHRA published updated guidance on GCP for clinical trials.
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  • 20 April 2023
  • 99
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (DSF)
3 April 2023 – the FDA published the draft guidance on marketing submission recommendations for AI/ML-enabled devices. Submit comments by 3 July 2023.
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  • 20 April 2023
  • 93
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act
5 April 2023 – the FDA published draft guidance on notifications of changes in the production of finished products or API.
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  • 20 April 2023
  • 120
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making
5 April 2023 – the FDA published draft guidance on patient-focused drug development for industry, FDA staff and other stakeholders. Submit comments by 5 July 2023.
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  • 20 April 2023
  • 98
Using Innovative Communication Methods to Increase Awareness and Understanding of CDER Guidance Documents: CDER’s Guidance Snapshot Pilot Program
10 April 2023 – the FDA published their Center for Drug Evaluation and Research (CDER) guidance snapshot pilot program.
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  • 20 April 2023
  • 149
A Risk-Based Approach to Monitoring of Clinical Investigations
12 April 2023 – the FDA published final Q&A guidance on risk-based monitoring of clinical investigations for industry.
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  • 20 April 2023
  • 95
EMA GCP IWG Points to Consider Regarding the Management of Ongoing Clinical Trials Impacted by Political Conflicts, Natural Disasters or Other Major Disruptions
5 April 2023 – the EMA published GCP IWG points to consider regarding the management of ongoing clinical trials impacted by disruptions in society.
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  • 20 April 2023
  • 90
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 April 2023 – the EMA published the reflection paper on the use of IRTs in clinical trials.
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  • 20 April 2023
  • 80
Clinical Trials Information System (CTIS) – Sponsor Handbook
12 April 2023 – the EMA published v3.02 of the CTIS sponsor handbook.
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  • 05 April 2023
  • 122
New Mobile Technologies Guidance Document for Human and Veterinary Medicinal Products
1 March 2023 – the Swissmedic published regulations on the use of QR codes on packaging and in medicinal product information.
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  • 05 April 2023
  • 143
Changes to the Guidance Document Product Information for Human Medicinal Products
1 March 2023 – the Swissmedic announced that detailed Information for healthcare professionals and Patient information templates are being withdrawn.
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  • 05 April 2023
  • 238
ICH Electronic Common Technical Document (eCTD) v4.0
17 March 2023 – the Swissmedic published eCTD v4.0 Step 4 Implementation Package.
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  • 05 April 2023
  • 111
Swissmedic Technical Update of CPP Order Form and New Version of the CPP Guidance Request
20 March 2023 – the Swissmedic published the updated version of the WHO pharmaceutical product (CPP) order form and the CPP guidance request.
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  • 05 April 2023
  • 100
Swissmedic Inspects Class I Manufacturers in Switzerland
27 March 2023 – the Swissmedic published the inspection report on 27 medical devices class I manufacturers in Switzerland.
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  • 05 April 2023
  • 108
The ICH S12 Guideline Reaches Step 4 of the ICH Process
17 March 2023 – the ICH announced the ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” reached Step 4 on 14 March 2023.
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  • 05 April 2023
  • 93
The ICH Q9(R1) Introductory Training Presentation Available on the ICH Website
20 March 2023 – the ICH announced the ICH Q9(R1) introductory training presentation is now available on their website.
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  • 05 April 2023
  • 109
Crafting an Intended Purpose in the Context of Software as a Medical Device (SaMD)
22 March 2023 – the UK MHRA published guidance on the context of software as a medical device.
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  • 05 April 2023
  • 97
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
1 March 2023 – the FDA published draft guidance on the development of monoclonal antibodies. Submit comments by 1 May 2023.
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  • 05 April 2023
  • 250
Q13 Continuous Manufacturing (CM) of Drug Substances and Drug Products
1 March 2023 – the FDA published the final ICH Q13 guidance on the CM of drug substances and drug products.
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  • 05 April 2023
  • 97
Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents (ARAs): Study Design, Data Analysis, and Clinical Implications
10 March 2023 – the FDA published the final guidance on the evaluation of gastric pH-dependent drug interactions with ARAs.
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  • 05 April 2023
  • 97
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
15 March 2023 – the FDA published draft Q&A guidance on the use of electronic systems, electronic records, and electronic signatures in clinical investigations. Submit comments by 15 May 2023.
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  • 05 April 2023
  • 115
Development of Local Anesthetic Drug Products with Prolonged Duration of Effect
15 March 2023 – the FDA published the draft guidance on the development of local anesthetic drug products. Submit comments by 14 June 2023.
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  • 05 April 2023
  • 203
Pharmacogenomic Data Submissions
17 March 2023 – the FDA published draft guidance on the pharmacogenomic data submissions. Submit comments by 20 June 2023.
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  • 05 April 2023
  • 102
Electronic Systems, Electronic Records, and Electronic Signatures Webinar
22 March 2023 – the FDA scheduled a webinar to be held on 25 April 2023, on electronic systems, electronic records, and electronic signatures.
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  • 05 April 2023
  • 125
FDA CDER & JHU CERSI Workshop | Addressing Challenges in the Design and Analysis of Rare Disease Clinical Trials: Considerations and Tools
24 March 2023 – the FDA announced a two-day virtual workshop on addressing challenges in the design and analysis of rare disease clinical trials.
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  • 05 April 2023
  • 122
Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics
24 March 2023 – the FDA published draft guidance on the pharmacogenomic data submissions. Submit comments by 24 May 2023.
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  • 05 April 2023
  • 143
Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions
29 March 2023 – the FDA published draft guidance on the premarket submissions for orthopedic non-spinal bone plates, screws, and washers. Submit comments by 29 May 2023.
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  • 05 April 2023
  • 120
Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and Office for Human Research Protections (OHRP)
30 March 2023 – the FDA published draft guidance on the review of research involving children as subjects for Review Boards, Investigators, and Sponsors. Submit comments by 30 May 2023.
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  • 05 April 2023
  • 128
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act
30 March 2023 – the FDA published the final guidance on the cybersecurity in medical devices.
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  • 05 April 2023
  • 149
Identification of Medicinal Products – Implementation and Use
30 March 2023 – the FDA published the final guidance on identifying medicinal products.
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  • 05 April 2023
  • 144
Draft Qualification Opinion for Stride Velocity 95th Centile as Primary Endpoint in Studies in Ambulatory Duchenne Muscular Dystrophy Studies
1 March 2023 – the EMA published the draft qualification opinion for the Stride Velocity 95th centile (SV95C) as primary endpoint in superiority studies.
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  • 05 April 2023
  • 165
Questions and Answers about the Raw Data Proof-of- Concept Pilot for Industry
8 March 2023 – the EMA published Q&A guidance on the scope, terms of participation and data submission process for the proof-of-concept pilot.
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  • 05 April 2023
  • 96
Guideline on Computerized Systems and Electronic Data in Clinical Trials
10 March 2023 – the EMA published the guidance on computerized systems and electronic data in clinical trials.
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  • 05 April 2023
  • 233
The New Unique Device Identifier (UDI) Helpdesk is Live
14 March 2023 – the European Commission (EC) announced that the new UDI helpdesk is live.
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  • 05 April 2023
  • 99
Evaluation Guide for GMP Regulatory Compliance Program – Audit Checklist
14 March 2023 – the EMA published revision 3 of the audit checklist for the GMP regulatory compliance program.
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  • 05 April 2023
  • 134
Clinical Trials Information System (CTIS): Virtual Walk-in Clinics
20 March 2023 – the EMA published the dates for the CTIS virtual walk-in clinics for 2023.
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  • 05 April 2023
  • 84
EMA’s Regulatory Science Strategy to 2025
22 March 2023 – the EMA published the mid-point achievements to end 2022.
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  • 05 April 2023
  • 163
Clinical Trials Information System (CTIS) Bitesize Talk: Document and Personal Data in CTIS
22 March 2023 – the EMA updated the presentation slides of CTIS bitesize talk on document and personal data in CTIS.
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  • 05 April 2023
  • 136
ICH Guideline Q5A(R2) on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
27 March 2023 – the EMA updated scientific guideline on ICH Q5A(R2).
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  • 05 April 2023
  • 217
Q&A on the Protection of Commercially Confidential Information (CCI) and Personal Data while Using CTIS
29 March 2023 – the EMA published version 1.1 of the Q&A guidance on how to protect personal data and CCI in CTIS.
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  • 06 March 2023
  • 175
Swissmedic Journal – January 2023
6 February 2023 – the Swissmedic published the January 2023 edition of its journal.
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  • 06 March 2023
  • 165
Applications for Clinical Trials with Medicinal Products and ATMPs (Advanced Therapy Medicinal Products)
13 February 2023 – the Swissmedic announced clinical trial applications can be submitted via new eGov portal.
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  • 06 March 2023
  • 173
Modifications to Guidance Document "Formal Requirements"
13 February 2023 – the Swissmedic published clarification of documentation to be submitted for co-marketing medicinal products; conditions can be the subject of collective applications.
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  • 06 March 2023
  • 153
Completed Pediatric Studies - Submission, Processing and Assessment
1 February 2023 – the UK MHRA published updated guidance on the submission, processing and assessment of all completed pediatric studies sponsored by Marketing Authorization Holders (MAHs).
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  • 06 March 2023
  • 168
Manufacture of Investigational Medicinal Products – Frequently Asked Questions
3 February 2023 – the UK MHRA inspectorate published FAQs on manufacturing IMP.
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  • 06 March 2023
  • 177
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
1 February 2023 – the FDA published draft guidance on the design and conduct of externally controlled trials. Submit comments by 2 May 2023.
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  • 06 March 2023
  • 158
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
10 February 2023 – the FDA published draft guidance on long-term clinical neurodevelopmental safety studies in neonatal product development.
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  • 06 March 2023
  • 130
Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA
17 February 2023 – the FDA published draft guidance on requesting and conducting PSG meetings. Submit comments by 22 April 2023.
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  • 06 March 2023
  • 183
Guidance for Industry and FDA Staff – Diagnostic X-Ray, Ultrasound Systems and Laser Equipment
21 February 2023 – the FDA published final guidance documents on diagnostic x-ray, ultrasound systems and laser equipment.
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  • 06 March 2023
  • 144
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment
24 February 2023 – the FDA published draft guidance on developing drugs for treating neovascular age-related macular degeneration. Submit comments by 30 May 2023.
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  • 06 March 2023
  • 125
Accelerating Clinical Trials in the European Union (ACT EU)
3 February 2023 – the EMA published the priority action 3 concept paper: an EU multi-stakeholder platform for improving clinical trials.
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  • 06 March 2023
  • 172
IRIS Guide to Registration and RPIs
6 February 2023 – the EMA published version 2.12 of the IRIS guide to registration and RPIs.
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  • 06 March 2023
  • 135
ICH Guideline Q9 (R1) on Quality Risk Management
6 February 2023 – the EMA published step 5 of the ICH Q9 (R1) guideline on quality risk management.
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  • 06 March 2023
  • 131
EMA/HMA Big Data Stakeholder Forum 2022 Report
13 February 2023 – the EMA published the December 2022 Big Data Stakeholder Forum report.
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  • 06 March 2023
  • 132
Pediatric Addendum on the Guidelines on Clinical Investigation of Medicinal Products for the Treatment and Prophylaxis of Venous Thromboembolic Disease
14 February 2023 – the EMA published the pediatric addendum of the guideline on clinical investigation for the treatment and prophylaxis of venous thromboembolic disease.
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  • 06 March 2023
  • 192
Questions & Answers Regarding Cannabis-derived Medicinal Products and the Scope of EU Herbal Monographs for Herbal Medicinal Products within the EU Medicines Legislation
15 February 2023 – the EMA published Q&A guidance on herbal medicinal products.
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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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