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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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  • 14 July 2018
  • 10
New FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
Draft Guidance published for receiving comments within 60 days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
  • 17
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
  • 54
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
  • 53
Pediatric investigation plans: questions and answers
Detailed guidance for sponsors applying for a pediatric investigation plan (PIP)
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  • 10 June 2018
  • 52
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
  • 58
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
  • 10957
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
  • 85
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
  • 101
Increasing oversight of API manufacturing through international collaboration
Report on the International API inspection program published
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  • 12 May 2018
  • 93
USFDA’s Revision 1 of the Special Protocol Assessment Guidance
In Effect: April 2018 – May 2020
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  • 08 May 2018
  • 99
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
  • 105
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
  • 136
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
  • 143
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
  • 136
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
  • 155
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
  • 145
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
  • 204
Clinical site initiation process remains lengthy and highly inefficient
New Tufts Center Report
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  • 26 March 2018
  • 218
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
  • 225
USFDA releases ICH Q11 guidance Q&A document
ICH Q11 Q&A document specifically about starting materials
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  • 12 March 2018
  • 277
USFDA releases ICH E6 R2 guidance
ICH guideline issued by the USFDA
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  • 05 March 2018
  • 269
USFDA BIMO Report presentation issued
The presentation gives an overview on the 2017 inspections and findings
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  • 04 March 2018
  • 272
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
  • 466
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
  • 321
CFDA moving to implement greater transparency over drug reviews
As full ICH member CFDA applies international standards
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  • 12 February 2018
  • 367
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
  • 352
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
  • 308
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
  • 384
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
  • 358
Small Business and Industry Assistance (SBIA) Documents in Chinese
US FDA provides SBIA documents in Chinese Translation
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  • 16 January 2018
  • 366
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
  • 389
New US FDA Draft Guidance
Refuse to File: NDA and BLA Submissions to CDER
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  • 08 January 2018
  • 333
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
  • 395
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
  • 398
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
  • 426
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
  • 430
New Edition of the International Compilation of Human Research Standards
2018 Edition now available
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  • 10 December 2017
  • 454
New EudraVigilance system is live
Better safety monitoring for patients across Europe
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  • 05 December 2017
  • 5400
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
  • 458
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
  • 488
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
  • 669
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
  • 490
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
  • 461
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
  • 496
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
  • 616
Widler & Schiemann open China Office
Business license obtained, first employee hired
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  • 24 October 2017
  • 509
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
  • 646
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
  • 535
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
  • 540
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
  • 509
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
  • 506
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
  • 647
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
  • 584
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
  • 562
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
  • 626
SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION
RISK PROPORTIONATE APPROACHES IN CLINICAL TRIALS
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  • 01 September 2017
  • 892
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
  • 586
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
  • 576
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
  • 601
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
  • 598
USFDA aims to foster generic drugs
A recent email announcement by USFDA lists the details
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  • 04 August 2017
  • 744
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
  • 653
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
  • 598
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
  • 626
Brookwood Academy launches “PV Training for All” Module
EFGCP GCP Discussion Group reviewed the first module
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  • 15 July 2017
  • 659
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
  • 556
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
  • 637
UK’s withdrawal from the EU
EMA publishes first thoughts on implications and mitigating actions.
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  • 04 July 2017
  • 822
China announced official ICH member
At the ICH Meeting in Montreal, China’s ICH membership was confirmed
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  • 01 July 2017
  • 602
Canada sets date for implementation of ICH E6 R2
The date shall be the 1st April 2018
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  • 20 June 2017
  • 649
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
  • 571
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
  • 837
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
  • 685
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
  • 1314
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
  • 893
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
  • 674
CFDA prunes medical device standards management guidelines
CFDA amends Medical Device Guideline
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  • 18 May 2017
  • 650
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
  • 744
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
  • 726
The EFPIA Disclosure Experience: An Update
EFPIA offers an update on media and industry responses
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  • 30 April 2017
  • 1092
EMA publishes new draft GCP guideline on TMF requirements
The deadline for comments is 11 July 2017
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  • 20 April 2017
  • 817
Small and Mid size Biotech Companies’ EDMS
Pocket EDMS URS include now TMF requirements
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  • 15 April 2017
  • 767
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
  • 888
China FDA publishes first report on self-inspection rule
Inspection Report for Drug Clinical Trial Data
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  • 05 April 2017
  • 772
New and revised FDA guidances for 2017
CDER’s plan for guidances for 2017
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  • 03 April 2017
  • 928
FDA and EMA to collaborate closer on GMP Inspections
Update to the 1998 agreed mutual recognition agreement
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  • 20 March 2017
  • 990
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
  • 821
FDA publishes OSI Statistics
OSI (Office of Scientific Investigations) publishes an overview of metrics on their homepage
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  • 12 March 2017
  • 7374
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
  • 1876
EMA invites comment on revised “Document Access Policy”
Comments from stakeholders invited until 18 May 2017
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  • 04 March 2017
  • 1344
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
  • 757
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
  • 168
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
  • 1411
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
  • 1190
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
  • 1153
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
  • 1249
Better monitoring of biological medicines
New chapter in guidelines on good pharmacovigilance practices
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  • 04 September 2016
  • 1276
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
  • 1295
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
  • 1468
EMA publishes Pharmacovigilance Report
Annual report of pharmacovigilance inspectors’ working party for 2014
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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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Quality Management of Pharmacovigilance Processes

We have developed a systematic approach to ensuring a continuous oversight on safety reporting whether in clinical trials or of spontaneous cases from marketed products. This methodology is based on the QbD and QRM principle and can be tailored to the customers' need.

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Corporate Compliance

With our experience we are best positioned to define the systems’ requirements, perform a risk analysis and define and rollout of processes for health care compliance.

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Through our network, we are uniquely placed to learn early of planned changes that may impact your operations and even more important we are able to put these in the right legal and regulatory context to guide you to make the right process and organizational changes or to confidently refuse any change.

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