Publications by ADAMAS Consulting Staff

• April 30, 2013
  29th SQA Annual Meeting & Quality College 28 April – 3 May 2013 Indianapolis, USA
• April 25, 2013
  New Asia & Pacific office opens in Mumbai
• March 15, 2013
  Realistic Audits – Responses to Reports
• February 15, 2013
  Paediatric Clinical Trials
• February 9, 2013
  New Career Opportunities at Adamas
• February 8, 2013
  GVP Consultant

Links

Organisations, Associations and Federations

The following links are to the web sites of the various regulatory and federal bodies covering the various aspects of GCP, GLP and Quality Assurance. This list is by no means exhaustive.

• Association of the British Pharmaceutical Industry (ABPI)
  A trade association of companies producing prescription medicines in the UK.
  
  
• British Association of Research Quality Assurance (BARQA)
  Interpretation and implementation of national and international regulations covering GLP, GCP and GMP.
  
  
• British Standards Institute
  The world's leading standards and quality services organisation, globally recognised as an independent and impartial body serving both the private and public sectors.
  
  
• Code of Federal Regulations - NARA
  The Code of Federal Regulations On-line - a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.
  
  
• Central Office for Research Ethics Committees (COREC)
  Provided by COREC to give people access to comprehensive and up-to-date information on the REC system in the UK.
  
  
• Data Protection Directive 95/46/EC
  Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.
  
  
• Drug Information Association
  A neutral global forum for the exchange and dissemination of information on the discovery, development, evaluation, and utilization of medicines and related healthcare technologies.
• Eudravigilance
  Pharmacovigilance in the European Economic Area (EEA).
• European Medicines Agency (EMA)
  The European system for the authorisation of medicinal products for human and veterinary use is designed to promote both public health and the free circulation of pharmaceuticals.
• European Forum for Good Clinical Practice (EFGCP)
  The European Forum for Good Clinical Practices (EFGCP) is a forum for considering the ethical, regulatory, and scientific framework of clinical research in Europe.
  
  
• EU Directives (GCP Directive and Clinical Trials Directive)
  This page contains specific links to EU Directive information.  This includes links to the EU Directive; EU Directive Implementing Texts; and respective National Regulatory Authorities for EU Member states and other European countries.
• FDAinfo.com website
  An internet site for locating FDA documents and other regulatory news and information.
  
  
• Food and Drug Administration (FDA)
  Authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and several other public health laws.
  
  
• FDA Guidance on Financial Disclosure
  Information on the FDA Guidance on Financial Disclosure.
  
  
• International Conference on Harmonisation (ICH)
  The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  
  
• Institute of Clinical Research
  The organisation (formerly The Association of Clinical Research for the Pharmaceutical Industry) provides a forum for education and sharing of best practice amongst clinical research professionals.
  
  
• International Organization for Standardization
  A worldwide federation of national standards bodies from some 130 countries, one from each country.
  
  
• Labcompliance
  Labcompliance, recommended global on-line resource for validation and compliance. View and download more than 100 pages and documents on www.labcompliance.com. Includes sections on computer validation, 21CFR part11, warning letters, and free newsletter and discussion forum.
  
  
• Medicines and Healthcare Products Regulatory Agency (MHRA)
  The MHRA was formed from a merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) on 1 April 2003.
• MHRA - Is it a Clinical Trial?
  MHRA algorithm and notes to help decide if a clinical study is covered by the EU Directive. In PDF format.
• Japanese National Institute of Health Sciences
  Responsible for conducting basic research to ensure the quality, efficacy and safety of a wide range of products that directly and indirectly affect the populace.
  
  
• Pharmaceutical Research and Manufacturers of America
  The Pharmaceutical Research and Manufacturers of America membership have a primary commitment to pharmaceutical research.
  
  
• Society of Quality Assurance
  Promoting the quality assurance profession through the discussion and exchange of idea.

Seminars, Presentations and Meetings

Please see below a list of seminars, conferences and meetings where ADAMAS Consulting will be attending.

ADAMAS Consulting Events

• 25-27/09/13 -2013 European QA conference, Germany

News

• April 30, 2013
  29th SQA Annual Meeting & Quality College 28 April – 3 May 2013 Indianapolis, USA
• April 25, 2013
  New Asia & Pacific office opens in Mumbai
• March 15, 2013
  Realistic Audits – Responses to Reports
• February 15, 2013
  Paediatric Clinical Trials
• January 15, 2013
  GVP Modules III and IV published in December 2012
• January 14, 2013
  Happy New Year! Adamas Consulting would like to wish you all every success in 2013.