Navigate Compliance Waters

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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  • 19 February 2018
  • 1
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
  • 10
CFDA moving to implement greater transparency over drug reviews
As full ICH member CFDA applies international standards
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  • 12 February 2018
  • 21
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
  • 36
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
  • 36
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
  • 48
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
  • 64
Small Business and Industry Assistance (SBIA) Documents in Chinese
US FDA provides SBIA documents in Chinese Translation
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  • 16 January 2018
  • 76
US FDA Draft Guidance: The Least Burdensome Provisions - Concept and Principles
Draft Guidance for Industry and Food and Drug Administration Staff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
  • 83
New US FDA Draft Guidance
Refuse to File: NDA and BLA Submissions to CDER
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  • 08 January 2018
  • 82
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
  • 97
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
  • 103
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
  • 128
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
  • 137
New Edition of the International Compilation of Human Research Standards
2018 Edition now available
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  • 10 December 2017
  • 153
New EudraVigilance system is live
Better safety monitoring for patients across Europe
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  • 05 December 2017
  • 326
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
  • 169
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
  • 198
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
  • 336
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
  • 203
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
  • 183
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
  • 210
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
  • 290
Widler & Schiemann open China Office
Business license obtained, first employee hired
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  • 24 October 2017
  • 225
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
  • 258
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
  • 220
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
  • 273
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
  • 242
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
  • 229
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
  • 290
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
  • 318
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
  • 289
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
  • 334
SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION
RISK PROPORTIONATE APPROACHES IN CLINICAL TRIALS
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  • 01 September 2017
  • 500
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
  • 302
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
  • 290
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
  • 336
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
  • 316
USFDA aims to foster generic drugs
A recent email announcement by USFDA lists the details
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  • 04 August 2017
  • 432
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
  • 376
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
  • 330
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
  • 343
Brookwood Academy launches “PV Training for All” Module
EFGCP GCP Discussion Group reviewed the first module
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  • 15 July 2017
  • 372
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
  • 304
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
  • 376
UK’s withdrawal from the EU
EMA publishes first thoughts on implications and mitigating actions.
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  • 04 July 2017
  • 415
China announced official ICH member
At the ICH Meeting in Montreal, China’s ICH membership was confirmed
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  • 01 July 2017
  • 314
Canada sets date for implementation of ICH E6 R2
The date shall be the 1st April 2018
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  • 20 June 2017
  • 376
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
  • 346
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
  • 508
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
  • 368
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
  • 895
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
  • 544
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
  • 392
CFDA prunes medical device standards management guidelines
CFDA amends Medical Device Guideline
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  • 18 May 2017
  • 393
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
  • 475
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
  • 424
The EFPIA Disclosure Experience: An Update
EFPIA offers an update on media and industry responses
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  • 30 April 2017
  • 467
EMA publishes new draft GCP guideline on TMF requirements
The deadline for comments is 11 July 2017
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  • 20 April 2017
  • 546
Small and Mid size Biotech Companies’ EDMS
Pocket EDMS URS include now TMF requirements
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  • 15 April 2017
  • 520
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
  • 565
China FDA publishes first report on self-inspection rule
Inspection Report for Drug Clinical Trial Data
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  • 05 April 2017
  • 522
New and revised FDA guidances for 2017
CDER’s plan for guidances for 2017
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  • 03 April 2017
  • 537
FDA and EMA to collaborate closer on GMP Inspections
Update to the 1998 agreed mutual recognition agreement
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  • 20 March 2017
  • 585
CFDA sets out principles for generic equivalency clinical trials
Follow up to last years’ release of new Bioequivalence guidelines
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  • 16 March 2017
  • 540
FDA publishes OSI Statistics
OSI (Office of Scientific Investigations) publishes an overview of metrics on their homepage
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  • 12 March 2017
  • 1645
Over 1,000 studies now recorded in EU register of post-authorisation studies
EU PAS Register increases transparency of research in medicines after they have been authorised in the EU
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  • 08 March 2017
  • 1485
EMA invites comment on revised “Document Access Policy”
Comments from stakeholders invited until 18 May 2017
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  • 04 March 2017
  • 986
ICH invites comments on Efficacy Guidelines
ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6
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  • 01 March 2017
  • 511
US Government publishes revision for the protection of human subjects
Widler & Schiemann’s interpretation of the new policy
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  • 18 November 2016
  • 122
Global GCP Guideline Amendment Adopted!
This amendment will now be implemented by ICH members through national and regional guidance
Read the ICH Press Release
  • 30 September 2016
  • 1094
Chinese Manufacturers struggle with Quality
While Chinese companies export about 50% of global APIs they struggle with international quality requirements
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  • 20 September 2016
  • 914
Transparency in drug regulation
Publication of assessment reports in Europe and Australia makes information on medicines more easily available
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  • 16 September 2016
  • 877
EU collaboration strengthens safety monitoring of medicines
European Commission publishes three-year report on implementation of pharmacovigilance legislation
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  • 08 September 2016
  • 941
Better monitoring of biological medicines
New chapter in guidelines on good pharmacovigilance practices
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  • 04 September 2016
  • 983
CFDA sets out punishments for counterfeit clinical trial data
Chinese authorities try to go against this trend by enforcing new legislations of punishment and fines
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  • 20 August 2016
  • 1025
FDA issues draft guidance on drug development in rare diseases
This draft guidance is open for comments for the next 60 days.
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  • 15 August 2016
  • 1166
EMA publishes Pharmacovigilance Report
Annual report of pharmacovigilance inspectors’ working party for 2014
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  • 10 August 2016
  • 1125
Audits in GCP and Beyond
The third issue of GCP auditing will be released soon
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  • 05 August 2016
  • 1229
UK TAKES AIM AT PHARMA PERKS
Sunshine rule announced in the UK
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  • 31 July 2016
  • 1103
CFDA issues extensive DRR draft amendments
The China FDA invites comments on their latest revision of their Drug Registration Regulation
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  • 31 July 2016
  • 1167
European Commission launches EU-U.S. Privacy Shield
A new framework for stronger protection for transatlantic data flow to build trust
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  • 31 July 2016
  • 1011
EMA to introduce Public Hearings
Vox Populi at EMA’s PRAC
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  • 31 July 2016
  • 1033
EMA plans to revise guidance on first-in-human clinical trials
Comments invited on a concept paper on changes intended to support best practices
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  • 21 March 2016
  • 1094
Draft Guidance on format of the Risk Management Plan (RMP) in the EU – in integrated format
The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers.
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  • 14 March 2016
  • 1365
EMA publishes two Drug Safety related Draft Guidance for Consultation
Guideline on Good Pharmacovigilance Practices (GVP) 3 - Module V – Risk management systems (Rev 2)
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  • 07 March 2016
  • 1376
FDA issues new Guidance on Safety Data in late Stage Trials
Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations
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  • 03 March 2016
  • 1558
Oliver Hellstern, MD joins Widler & Schiemann
Oliver Hellstern, Expert in Drug Safety, joins Widler & Schiemann Ltd. on March 1st, 2016
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  • 22 February 2016
  • 1480
Stronger data protection rules for Europe
The EU adopts the data protection reform package
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  • 15 February 2016
  • 1482
EMA launches new IT System
On 1 February 2016, the Agency is launching a new IT system to answer stakeholders’ IT-related queries and services.
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  • 10 February 2016
  • 1425
Germany: New Anti-Corruption Law
Fighting Private Sector Bribery and Cross-Border Corruption
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  • 09 February 2016
  • 1485
EMA delays enforcement of new Clinical Trial Regulation
EMA will not enforce the new Clinical Trial Regulation as planned in May 2016 – 2017 is more likely
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  • 09 February 2016
  • 1567
New FDA Draft Guidance on Safety Assessment for IND Safety Reporting
The new Draft Guidance on Safety Assessment for IND Safety Reporting is open for comments to be sent to FDA
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  • 21 January 2016
  • 1404
Endpoint Adjudication Survey Results are in!
The recently launched endpoint adjudication survey results are out:
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  • 14 January 2016
  • 1428
EMA aims to reinforce compliance with good clinical practice
Regulatory information - Replacement of GCP non-compliant pivotal studies in centralised marketing-authorisation applications not accepted
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  • 07 January 2016
  • 1254
New FDA Guidance on meetings with Biosimilar Companies
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants: Guidance for Industry
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  • 06 January 2016
  • 1347
FDA issues new Draft Guidance on Communication between Sponsors and FDA
Best Practices for Communication Between IND Sponsors and FDA During Drug Development-Guidance for Industry and Review Staff
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  • 20 December 2015
  • 1536
Beat Widler to present at the 2nd Academic Symposium
Beat Widler is invited to speak on the Clinical Research Quality & China New Drug 50 Roundtable Forum in Beijing, China
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  • 15 December 2015
  • 1343
ACRES and Ethical GmbH, Switzerland to collaborate on eAdjudication
ACRES integrates eAdjudication into shared global platform of integrated technologies
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  • 10 December 2015
  • 1601
Widler & Schiemann to represent ACRES at EMA Inspectors Working Group
Peter Schiemann represented ACRES, the Alliance for Clinical Research Excellence and Safety at the EMA IWG Meeting on EDC systems and risk based monitoring in Clinical Trials
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  • 05 December 2015
  • 1363
ICH announces organizational changes!
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly and Management Committee on 23 October 2015
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