Calendar of Events:

 

17th-18th February 2017

Drug Safety & Pharmacovigilance

 

24th-25th  March 2017

Non-Clinical Safety Testing, Clinical Pharmacology & Therapeutics

 

21st-22nd  April 2017
Medicines Regulation

 

26th-27th May 2017

Statistics & Data Management

 

28th May 2017

Critical Appraisal
Skills Workshop

 

23rd-24th June 2017

Clinical Development
& Discovery Medicine

 

21st-22nd July 2017

Healthcare Marketplace

 

8th September 2017

MCQ Exam Technique
& Mock Exam Modules

 

6th-7th October 2017

SAQ & Critical Appraisal Exam Technique &
Mock Exam Modules

 

 

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Baxter Medical Ltd

Expert Solutions for the Pharmaceutical Industry

 

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Services

Baxter Medical provides the following services:

 

Medical Affairs and Market Access

  • Development, review, approval and certification of promotional and non-promotional materials and activities to support product launch and subsequent commercialisation
  • Design and preparation of submissions to NICE, SMC and AWMSG
  • Design and preparation of value dossiers, budget impact models, managed access agreements and other tools to support market access
  • Preparation of applications for inclusion in local formularies, NHS Drug Tariff, NHS Supply Chain catalogue and HRG / OPCS Codes
  • Design and conduct of phase IV studies and outcomes research
  • Conference symposia, presentations and advisory boards
  • Publication planning and development
  • Systematic literature reviews
  • Medical writing, e.g. preparation of manuscripts for publication in scientific journals, product core claims and promotional copywriting
  • Design and preparation of patient support programmes and materials
  • Therapeutic area training, e.g. to sales force

 

Regulatory Affairs

  • Preparation of Clinical Overviews and Clinical Summaries to support Marketing Authorisation applications
  • Preparation of Clinical Overviews/Expert Statements to support variations, extensions and renewals of Marketing Authorisations
  • Regulatory strategy for global development plans including orphan drug designations and paediatric investigation plans
  • Preparation for and attendance at scientific advice and other meetings/oral hearings with competent authorities

 

Drug Safety and Pharmacovigilance

  • Preparation of DSURs, PSURs and other pharmacovigilance reports and documentation
  • Detection and evaluation of safety signals
  • Preparation of Core Safety Information and Risk Management Plans
  • Preparation of the safety sections of the CTD
  • Design of PASS and PAES Studies
  • Preparation for and management of pharmacovigilance inspections by competent authorities
  • Pharmacovigilance training, e.g. trial investigators

 

Due Diligence

  • Data review and gap analysis
  • Review and analysis of Target Product Profiles
  • Assessment of medical need and market potential
  • Assessment of benefit-risk profiles
  • Generation and/or review of regulatory and clinical development strategies
  • Identification and review of key milestones

©Baxter Medical Ltd 2008-2017. All Rights Reserved.