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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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  • 10 December 2018
  • 2
EMA use of patient disease registries for regulatory purposes
Methodological and operational considerations by a cross-committee task force on Registries
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  • 03 December 2018
  • 132
FDA Facilitates the Use of Surrogate Endpoint in Drug Development
CDER small business and industry assistance podcast news from November 2018
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  • 20 September 2018
  • 837
EMA Draft questions and answers on Data Monitoring Committees issues
A Supplement to the CHMP Data Monitoring Committee Guideline
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  • 15 September 2018
  • 176
EMA on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
New Draft Guideline issued; consultation end date: July 2019
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  • 10 September 2018
  • 185
FDA Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
New FDA Guidance for Industry
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  • 05 September 2018
  • 189
New FDA Draft Guidance on Hematologic Malignancy and Oncologic Disease
Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development
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  • 03 September 2018
  • 264
New FDA draft Guidance on Expansion Cohorts
Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
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  • 16 August 2018
  • 253
CNDA seeks feedback on latest GCP Regulation Draft
The Chinese National Drug Administration (CNDA) is looking for feedback by August 16, 2018
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  • 12 August 2018
  • 272
FDA Final Guidance for Industry: ANDA Submissions
Amendments to Abbreviated New Drug Applications under GDUFA
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  • 08 August 2018
  • 252
FDA Announces Two Initiatives on Quality Metrics Program Development
FDA is looking for feedback on their recent Quality Initiatives on Metrics
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  • 04 August 2018
  • 211
FDA Publishes List of Surrogate Endpoints Used in Drug Approvals
The list includes surrogate endpoints for approval of new drug applications
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  • 02 August 2018
  • 216
EMA Policy 70 submissions temporarily suspended as of 1 August
Phase 2 of EMA’s Business Continuity Plan soon to come into effect
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  • 28 July 2018
  • 282
Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
Publication of updated Q+As and practical guidance
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  • 21 July 2018
  • 292
Re-issuing of USFDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA (Biosimilar User Fee Act) Products
Comments are encouraged within 90 days of issuance
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  • 14 July 2018
  • 327
New FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
Draft Guidance published for receiving comments within 60 days
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  • 07 July 2018
  • 241
Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
Agreement now operational between 14 EU Member States and FDA
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  • 20 June 2018
  • 251
Informed Consent for Pediatric Clinical Trials in Europe 2015 - Updated
Update from May 2018 detailing procedures in all member states
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  • 15 June 2018
  • 401
Pediatric investigation plans: questions and answers
Detailed guidance for sponsors applying for a pediatric investigation plan (PIP)
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  • 10 June 2018
  • 290
EMA draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice
EMA asks for comments on the new guideline by end of August 2018
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  • 06 June 2018
  • 291
USFDA issue new Guidance on Clinical Trial Imaging Endpoint Process Standards
Final Guidance for Industry effective April 2018
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  • 06 June 2018
  • 14067
US FDA issues Institutional Review Board (IRB) Written Procedures
Final Guidance for Institutions and IRBs effective May 2018
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  • 20 May 2018
  • 281
New EMA Draft Guideline on Clinical Evaluation of Vaccines
Comments can be sent in until 30th October 2018
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  • 16 May 2018
  • 318
Increasing oversight of API manufacturing through international collaboration
Report on the International API inspection program published
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  • 12 May 2018
  • 339
USFDA’s Revision 1 of the Special Protocol Assessment Guidance
In Effect: April 2018 – May 2020
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  • 08 May 2018
  • 311
New USFDA draft Guidance on in-vitro Diagnostics in Oncology Trials
Comments and suggestions regarding this draft document should be submitted within 60 days of publication
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  • 04 May 2018
  • 309
USFDA issue new draft Guidance on inclusion of pregnant women in clinical trials
Comments and suggestions regarding this draft document should be submitted within 60 days of publication
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  • 02 May 2018
  • 402
Beat Widler to moderate session at EFGCP Workshop 18th June 2018, London
Investigators meet Inspectors workshop by EFGCP in the light of ICH E6R2
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  • 20 April 2018
  • 474
New tracking tool for EMA’s relocation to Amsterdam
Tool gives transparent overview of main milestones and work stream deliverables
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  • 15 April 2018
  • 424
USFDA’s Compliance Policy for Combination Product Post-Marketing Safety Reporting
Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
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  • 10 April 2018
  • 402
China’s NHFPC and CFDA to be downgraded amid ministerial reshuffle
The National People’s Congress officially approved plans for a ministry shakeup
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  • 05 April 2018
  • 358
CHMP adopts new Guideline on Good Pharmacogenomic Practice
The new guideline adopted by the CHMP will become effective on 1st September 2018
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  • 31 March 2018
  • 405
Clinical site initiation process remains lengthy and highly inefficient
New Tufts Center Report
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  • 26 March 2018
  • 470
China’s CDE clarifies NDA dossier requirements
A wave of PD-1/PD-L1 mAb application pushes CDE to act
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  • 19 March 2018
  • 459
USFDA releases ICH Q11 guidance Q&A document
ICH Q11 Q&A document specifically about starting materials
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  • 12 March 2018
  • 496
USFDA releases ICH E6 R2 guidance
ICH guideline issued by the USFDA
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  • 05 March 2018
  • 479
USFDA BIMO Report presentation issued
The presentation gives an overview on the 2017 inspections and findings
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  • 04 March 2018
  • 509
General Court confirms EMA approach to transparency
Three rulings clarify the scope of commercial confidentiality with regard to authorized medicines
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  • 19 February 2018
  • 1041
CFDA’s “Orange Book” launch marks new era of quality generics
Standards for generic products will ensure quality throughout the Chinese market
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  • 16 February 2018
  • 564
CFDA moving to implement greater transparency over drug reviews
As full ICH member CFDA applies international standards
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  • 12 February 2018
  • 677
CFDA applying ICH technical guidelines to drug filings, safety management
CFDA’s follow up on full ICH membership
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  • 08 February 2018
  • 562
EMA surveys pharma companies on their preparedness for Brexit
Planning of regulatory steps needed to ensure medicines remain on EU market
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  • 04 February 2018
  • 512
Best Practices for Communication Between IND Sponsors and USFDA During Drug Development
Guidance for Industry and Review Staff
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  • 01 February 2018
  • 622
Update: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Guidance for Industry and Food and Drug Administration Staff
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  • 20 January 2018
  • 570
Small Business and Industry Assistance (SBIA) Documents in Chinese
US FDA provides SBIA documents in Chinese Translation
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  • 16 January 2018
  • 625
US FDA Draft Guidance: The Least Burdensome Provisions - Concept and Principles
Draft Guidance for Industry and Food and Drug Administration Staff
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  • 12 January 2018
  • 630
New US FDA Draft Guidance
Refuse to File: NDA and BLA Submissions to CDER
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  • 08 January 2018
  • 519
Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
EMA and European Commission publish updated Q&As
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  • 04 January 2018
  • 1124
EMA adopts ICH guideline E17
ICH guideline E17 on general principles for planning and design of multi-regional clinical trials coming into effect in June 2018
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  • 31 December 2017
  • 590
Henk de Wilde joins Widler & Schiemann Ltd. as Managing Director
Henk de Wilde will join Widler & Schiemann Ltd. in Switzerland in January 2018
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  • 20 December 2017
  • 643
USFDA Widens Scope of Navigator – Information Tool for Expanded Access
Two examples of the recent steps US FDA has taken in pursuit of improving their expanded access and orphan drug program
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  • 15 December 2017
  • 865
New Edition of the International Compilation of Human Research Standards
2018 Edition now available
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  • 10 December 2017
  • 642
New EudraVigilance system is live
Better safety monitoring for patients across Europe
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  • 05 December 2017
  • 5791
EU-US mutual recognition of inspections of medicines manufacturers enters operational phase
Major milestone is a testimony to mutual trust
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  • 01 December 2017
  • 706
Xi Chen joins Widler & Schiemann Ltd. China as Managing Director
Ms. Xi Chen, MSc, MBA, has joined WS China with more than 20 years of industry experience
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  • 20 November 2017
  • 819
China will allow private hospitals and other health related institutions
In his speech at the 19th National Congress of the CPC, President Xi Jinping emphasized the focus on “Healthy China”
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  • 16 November 2017
  • 910
China now accepting Clinical Trial Data from other Countries
CFDA issued a new guideline announcing that for submissions clinical trial data from other countries will be accepted
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  • 12 November 2017
  • 733
Updates on EMA Guideline on Good Pharmacovigilance Practice
Two of the updated Modules will become effective in November 2017
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  • 08 November 2017
  • 672
New USFDA Draft Guidance on ANDA and 505(b)(2) Application
USFDA provides a guide for decision making whether to submit an ANDA or 505(b)(2)
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  • 04 November 2017
  • 707
Update on USFDA Draft Guidance on REMS
Update on format and content of a REMS document – Revision of the 2009 Guidance
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  • 01 November 2017
  • 908
Widler & Schiemann open China Office
Business license obtained, first employee hired
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  • 24 October 2017
  • 729
New Pharmacovigilance (PV) Inspection Guide by Australian Health Authority
The Therapeutics Goods Administration (TGA) issued a new guidance for medicine sponsors on PV
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  • 18 October 2017
  • 984
China FDA to issue catalogue of all drugs marketed in China
A Chinese Version of the USFDA’s “Orange Book” will be available soon
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  • 14 October 2017
  • 738
Patient safety: Commission adopts acts on Good Manufacturing Practices for medicines
Focus on Marketed Products and Investigational Medicinal Products
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  • 08 October 2017
  • 759
USFDA is advancing the Goals of the Orphan Drug Act
An Update from the USFDA Commissioner on the achievements to date
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  • 04 October 2017
  • 817
Final USFDA Guidance on Real World Evidence and Medical Devices
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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  • 30 September 2017
  • 786
New USFDA Draft Guidance on submitting REMS in SPL Format
Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling Guidance for Industry
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  • 16 September 2017
  • 941
The new 2017 Good Clinical Practice Q&A Guide is available!
Dr. Beat Widler is a reappearing author for this guide and member of the editorial board
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  • 12 September 2017
  • 922
EMA Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: pediatric population
New Guideline open for comments until 13th October 2017
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  • 08 September 2017
  • 808
EMA prepares for Brexit
Business continuity plan aims to preserve Agency’s ability to protect public and animal health
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  • 04 September 2017
  • 892
SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION
RISK PROPORTIONATE APPROACHES IN CLINICAL TRIALS
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  • 01 September 2017
  • 1397
Dr. Oliver Hellstern invited as lecturer for Pharmacovigilance at ETH Zurich
Our PV Practice Leader, Dr. Oliver Hellstern, to teach about Pharmacovigilance at the University ETH Zurich
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  • 01 September 2017
  • 767
Strengthening EU-US cooperation in medicine inspections
New commitment allows FDA to share full inspection reports with European Commission and EMA
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  • 20 August 2017
  • 807
New ICH E19 Guideline in development on Optimisation of Safety Data Collection
Guidance on targeted approach to safety data collection
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  • 16 August 2017
  • 799
EMA: Revised Guideline for Entry into Human
Guidance outlines strategies to identify and mitigate risks for trial participants
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  • 08 August 2017
  • 786
USFDA aims to foster generic drugs
A recent email announcement by USFDA lists the details
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  • 04 August 2017
  • 1103
Update of the BIMO Guidance Manual
USFDA announced that a major revision BIMO manual was issued in April 2017 – Guidance for FDA staff
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  • 31 July 2017
  • 851
New USFDA Draft Guideline on Electronic Records and Signatures
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 - Questions and Answers
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  • 22 July 2017
  • 853
FDA Updates Part 11 Guidance for Clinical Trials to Include Mobile and Wearable Tech
Public Comments are invited until late August 2017
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  • 18 July 2017
  • 842
Brookwood Academy launches “PV Training for All” Module
EFGCP GCP Discussion Group reviewed the first module
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  • 15 July 2017
  • 874
New action plan to support SMEs as drivers of pharmaceutical innovation
16 actions identified for implementation in 2017-2020
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  • 12 July 2017
  • 733
EMA and EUnetHTA step up interaction to align data requirements
A new joint platform for parallel consultation will provide advice to medicine developers and facilitate access to medicines for patients
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  • 08 July 2017
  • 809
UK’s withdrawal from the EU
EMA publishes first thoughts on implications and mitigating actions.
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  • 04 July 2017
  • 1077
China announced official ICH member
At the ICH Meeting in Montreal, China’s ICH membership was confirmed
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  • 01 July 2017
  • 870
Canada sets date for implementation of ICH E6 R2
The date shall be the 1st April 2018
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  • 20 June 2017
  • 895
East African Community looks to EMA as model for future regional agency
EMA and East African regulators met on 18-19 May 2017
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  • 16 June 2017
  • 757
Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions
Management Board endorsement starts countdown for stakeholders to get ready for launch of improved system in November 2017
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  • 12 June 2017
  • 1114
No timeline at FDA for adoption of ICH E6 (R2)
Widler & Schiemann asked the USFDA as no information can be found on their homepage
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  • 08 June 2017
  • 934
EMA issues Draft Guideline on Serious Breaches
Breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
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  • 04 June 2017
  • 1588
China submits conditional application to join ICH
At DIA China Annual Meeting China Secretary Yuan Lin confirmed China’s application
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  • 01 June 2017
  • 1198
Widler & Schiemann Ltd. and Beijing Jingwei Chuanqi Medicines Service Ltd. start Joint Venture in China
WS China will be a joint venture together with our partner 3Audit
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  • 25 May 2017
  • 914
CFDA prunes medical device standards management guidelines
CFDA amends Medical Device Guideline
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  • 18 May 2017
  • 879
Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials
FDA’s CDER and C-Path’s PRO consortium second workshop
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  • 10 May 2017
  • 944
Summary of changes to the guidance of publication of clinical trial data by EMA
Update to the guidance published on March 03, 2016
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  • 05 May 2017
  • 942
The EFPIA Disclosure Experience: An Update
EFPIA offers an update on media and industry responses
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  • 30 April 2017
  • 1305
EMA publishes new draft GCP guideline on TMF requirements
The deadline for comments is 11 July 2017
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  • 20 April 2017
  • 1076
Small and Mid size Biotech Companies’ EDMS
Pocket EDMS URS include now TMF requirements
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  • 15 April 2017
  • 939
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs Release: 15.04.2017 02:03:36
Medicines where suitable alternative data are available can remain on market
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  • 10 April 2017
  • 1193
China FDA publishes first report on self-inspection rule
Inspection Report for Drug Clinical Trial Data
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  • 05 April 2017
  • 980
New and revised FDA guidances for 2017
CDER’s plan for guidances for 2017
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  • 03 April 2017
  • 1177
FDA and EMA to collaborate closer on GMP Inspections
Update to the 1998 agreed mutual recognition agreement
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