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13-14 May 2008 • Hilton Singapore • Singapore

2-3 June 2008 • Dorint Hotel Don Giovanni Prague, Czech Republic

Compliance Strategies from Discovery to Commercialisation is taught by Dr. Philip Marshal whose professional experience and expertise spans more than 30 years growing from his days as a bench chemist and extending to drug development, pre-clinical and clinical trials design & management, scale-up and technology transfer, manufacturing, quality assurance, patent matters and international regulatory affairs. Dr. Marshall has held management positions with major pharmaceutical companies such as Hospira, Pfizer and until recently was General Manager, Scientific Affairs at Sigma Pharmaceuticals, Australia where he had corporate responsibility for strategic planning in R&D, quality, compliance, scientific and regulatory affairs.

Course Highlights

 

Organised by:

Supported by:

Media Partners:

 
  • Overview of the international regulatory environment
  • Key compliance issues from drug discovery through to commercialisation
  • Principles of pharmaceutical GXP and compliance
  • Principles of medicinal chemistry and molecular targeting that are used for candidate selection and optimisation and instrumental techniques to gain useful information
  • Early pre-formulation/formulation and biopharmaceutics information to aid in selection of lead compound for development and predict potential problems
  • Various dosage forms, routes of administration and drug delivery systems and how to select and optimise for lead compound(s) and develop a target product profile (TPP).
  • Toxicology and safety requirements for the pre-clinical program and establish dose for Phase I studies
  • Key stages of the clinical program

    This course is highly recommended for everyone charged with the responsibility of achieving successful product development from lab to market. If you want to play a proactive role in Drug Discovery, Development & Marketing, then this is the one course you must attend.

    Course Objectives

    After this course you will be able to:-
    Complete an internal regulatory risk assessment for your product.
    Identify, assess and quantify risks and create mitigation and contingency strategies.
    Calculate the risks associated with non-compliance in a DDD program
    Communicate appropriate scientific information prior to FDA, EU approval and identify red flags before they reach FDA, EU
    Develop a regulatory project development plan
    Develop a regulatory due diligence checklist e.g. for product acquisition
    Apply best practices to the development of new product initiatives

    Register Now!
    Places are limited to maximize learning and sharing. For enquiries or to request for a brochure, please contact :

    Helen Lee
    Marketing Manager
    Magenta Global Pte Ltd
    helen.lee@magenta-global.com.sg
    Tel: (65) 6391 2549
    Fax: (65) 6392 3592