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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 2017
  • 13
New EudraVigilance system is live
Better safety monitoring for patients across Europe
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  • 05 December 2017
  • 43
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
  • 51
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
  • 71
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
  • 129
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
  • 84
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
  • 84
New USFDA Draft Guidance on ANDA and 505(b)(2) Application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
  • 97
Update on USFDA Draft Guidance on REMS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
  • 116
Widler & Schiemann open China Office
Business license obtained, first employee hired
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  • 24 October 2017
  • 115
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
  • 141
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
  • 127
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
  • 170
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
  • 149
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
  • 132
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
  • 193
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
  • 212
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
  • 192
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
  • 220
SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION
RISK PROPORTIONATE APPROACHES IN CLINICAL TRIALS
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  • 01 September 2017
  • 293
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
  • 201
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
  • 198
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
  • 241
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
  • 217
USFDA aims to foster generic drugs
A recent email announcement by USFDA lists the details
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  • 04 August 2017
  • 302
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
  • 268
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
  • 264
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
  • 236
Brookwood Academy launches “PV Training for All” Module
EFGCP GCP Discussion Group reviewed the first module
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  • 15 July 2017
  • 286
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
  • 210
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
  • 283
UK’s withdrawal from the EU
EMA publishes first thoughts on implications and mitigating actions.
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  • 04 July 2017
  • 306
China announced official ICH member
At the ICH Meeting in Montreal, China’s ICH membership was confirmed
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  • 01 July 2017
  • 214
Canada sets date for implementation of ICH E6 R2
The date shall be the 1st April 2018
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  • 20 June 2017
  • 280
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
  • 278
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
  • 374
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
  • 279
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
  • 644
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
  • 428
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
  • 300
CFDA prunes medical device standards management guidelines
CFDA amends Medical Device Guideline
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  • 18 May 2017
  • 307
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
  • 395
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
  • 330
The EFPIA Disclosure Experience: An Update
EFPIA offers an update on media and industry responses
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  • 30 April 2017
  • 384
EMA publishes new draft GCP guideline on TMF requirements
The deadline for comments is 11 July 2017
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  • 20 April 2017
  • 449
Small and Mid size Biotech Companies’ EDMS
Pocket EDMS URS include now TMF requirements
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  • 15 April 2017
  • 439
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
  • 471
China FDA publishes first report on self-inspection rule
Inspection Report for Drug Clinical Trial Data
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  • 05 April 2017
  • 420
New and revised FDA guidances for 2017
CDER’s plan for guidances for 2017
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  • 03 April 2017
  • 440
FDA and EMA to collaborate closer on GMP Inspections
Update to the 1998 agreed mutual recognition agreement
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  • 20 March 2017
  • 485
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
  • 443
FDA publishes OSI Statistics
OSI (Office of Scientific Investigations) publishes an overview of metrics on their homepage
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  • 12 March 2017
  • 873
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
  • 1195
EMA invites comment on revised “Document Access Policy”
Comments from stakeholders invited until 18 May 2017
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  • 04 March 2017
  • 813
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
  • 418
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
  • 97
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
  • 977
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
  • 794
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
  • 758
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
  • 817
Better monitoring of biological medicines
New chapter in guidelines on good pharmacovigilance practices
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  • 04 September 2016
  • 865
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
  • 942
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
  • 1037
EMA publishes Pharmacovigilance Report
Annual report of pharmacovigilance inspectors’ working party for 2014
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  • 10 August 2016
  • 987
Audits in GCP and Beyond
The third issue of GCP auditing will be released soon
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  • 05 August 2016
  • 1069
UK TAKES AIM AT PHARMA PERKS
Sunshine rule announced in the UK
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  • 31 July 2016
  • 960
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
  • 1034
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
  • 886
EMA to introduce Public Hearings
Vox Populi at EMA’s PRAC
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  • 31 July 2016
  • 912
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
  • 1003
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
  • 1272
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
  • 1260
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
  • 1424
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
  • 1387
Stronger data protection rules for Europe
The EU adopts the data protection reform package
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  • 15 February 2016
  • 1350
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
  • 1310
Germany: New Anti-Corruption Law
Fighting Private Sector Bribery and Cross-Border Corruption
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  • 09 February 2016
  • 1361
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
  • 1436
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
  • 1291
Endpoint Adjudication Survey Results are in!
The recently launched endpoint adjudication survey results are out:
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  • 14 January 2016
  • 1318
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
  • 1161
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
  • 1242
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
  • 1443
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
  • 1249
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
  • 1498
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
  • 1262
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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  • 02 December 2015
  • 1306
MHRA wants to see paper records retained
MHRA commented in their discussion forum on retention of trial records
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  • 21 November 2015
  • 1287
Survey on endpoint adjudication launched!
Mimmo Garibbo, Dirctor at Ethical GmbH launches survey on endpoint adjudication
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  • 17 November 2015
  • 276
2nd Academic Symposium on the Clinical Research Quality & China New Drug 50 Roundtable Forum in Beijing
Beat Widler will speak at the conference about "Development and Management New Trends of Global Clinical Research" on December 4th 2015
  • 14 November 2015
  • 1704
Beat Widler co-authors article on adjudication methods
An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals
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  • 07 November 2015
  • 1287
ICH goes Risk-based!
Beat Widler co-authors article in Applied Clinical Trials (ACT)
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  • 02 November 2015
  • 1340
CluePoints and Widler & Schiemann announce Partnership
CluePoints and WSQMS signed a partnership agreement to support each other in projects with clients
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  • 01 October 2015
  • 1816
Free Webinar on Implications of ICH E6 Amendment
In a webinar on October 20th, 2015, Clinerion and Widler & Schiemann will explain the implications of the ICH E6 Amendment on Managing Clinical Trials
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  • 01 October 2015
  • 1384
Workshop on Risk-based Monitoring
Artem Andrianov and Peter Schiemann to lead workshop at PCT Conference in November in Hamburg, Germany
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  • 01 October 2015
  • 1305
Cheaper Generics for poor Countries
European Commission backs bypassing drug patents for poor nations
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  • 31 August 2015
  • 2085
DIA Global Forum Online August
Contribution on Quality Matters by Beat Widler & Peter Schiemann
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  • 20 August 2015
  • 1744
EMA Draft Guideline on the Scientific Application and the practical Arrangements necessary to implement Regulation (EC) No 507/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use falling within the Scope of Regulation (EC)
This draft guideline has been updated in order to reflect the experiences accumulated with conditional marketing authorisations and is therefore released for repeated public consultation.
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  • 15 August 2015
  • 1301
EMA Draft Guideline on the Scientific Application and the practical Arrangements necessary to implement the Procedure for accelerated Assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004
EMA provides further clarification on the accelerated assessment procedure
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  • 10 August 2015
  • 1647
Beat Widler authors article on Inspection Readiness
The German Society for Pharmaceutical Medicine published an article by Beat Widler on Inspection Readiness (in German)
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  • 05 August 2015
  • 1342
FDA Draft Guidance on Metrics in Manufacturing
FDA released its draft guidance on metrics for manufacturing for comments within the next 60 days
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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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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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