First Asia-Pacific Educational Workshop Non-Biological Complex Drugs 2013

8 October 2013, Kuala Lumpur, Malaysia

In 2013, GaBI organized the First Asia-Pacific Educational Workshop on Non-Biological Complex Drugs on 8 October 2013 in Kuala Lumpur, Malaysia, in collaboration with the Ministry of Health Malaysia.

The First Asia-Pacific Educational Workshop on Non-Biological Complex Drugs (NBCDs) is an interactive workshop for regulators, academics, and medical specialists (gynaecologists/nephrologists who are key opinion leaders) from Asia covering Indonesia, Malaysia, Pakistan, Philippines, Singapore and Thailand. The workshop was attended by 25 persons including speakers coming from Belgium, France, Portugal, South Korea, Switzerland and USA.

The educational workshop intends to raise awareness to drug regulators and practising physicians on the efficacy, safety and quality nature of follow-on NBCDs. Representatives from regulatory authorities, academia and medical specialists joined together in this educational workshop to foster open discussions on the issues surrounding best practice in the regulatory requirements on and use and monitoring of follow-on NBCDs, as well as interchangeability and substitution of these medicines.

A meeting report of this workshop has been published in GaBI Journal.

Click here to view the event photos.

You can download the speakers’ presentations of this educational workshop:

Best practices for the regulation, use and monitoring of follow-on non-biological complex drugs

‘Generic’ or follow-on versions of small molecules, biological, and non-biological complex drugs: the scientific and regulatory gap when similarity but not sameness applies

Measuring complexity – characterization of non-biological complex drug and regulatory consequences

Is substitution of intravenous iron with a ‘similar’ acceptable clinical practice?

Substitution: clinical observations of differences in efficacy and efficiency (input versus output)

Non-clinical aspects of the development of non-biological complex drugs – the regulatory position in the European Union

Contact us for further information.

Last update: 2022-08-17 Go Back Print

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