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About Penny Field

Penny Field has worked in the pharmaceutical industry for 25 years; the past 23 years have been focused on the development and registration of medicinal products. Penny has consulted on the regulatory strategy and development of monoclonal antibodies, immunotherapeutics, recombinant proteins, gene therapies and biosimilars. Additionally Penny has experience in the registration of New Chemical Entities (NCE) and generics. She has prepared Investigational New Drug (IND), Clinical Trial Exemption (CTX) and Marketing Applications for recombinant proteins, vaccines, NCE, generics and blood products.

International Conference on Harmonization (ICH): A global collaboration

No discussion of the regulation and development of medicinal products is complete without mentioning the critical role of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Prior to 1990, the technical requirements for registration of drugs were significantly different between the three major pharmaceutical jurisdictions – namely […]

By |August 30th, 2014|Drug Development, Drug Regulation|0 Comments

Does the benefit of the medicine outweigh the risk?

It was only after I started working in drug regulation that I fully appreciated the role of risk/benefit analysis for medicines. I thinks it’s a testimony to the skill of the regulators that balancing the benefit of a medicine against the risk has been performed so well that, as a consumer, I expected any […]

By |August 29th, 2014|Uncategorized|0 Comments

What’s required to register a prescription medicine?

This is a helicopter view of the regulatory requirements to gain approval for a prescription medicine in Australia. For detailed information it’s best to refer to the Therapeutic Goods Administration (TGA) website.

In order to be able to sell a therapeutic good in Australia it’s necessary to have the product included on the Australian Register […]

By |August 28th, 2014|Drug Regulation|0 Comments

Why medicines are so highly regulated

You may have wondered why it takes so long to develop a new medicine and why there is such a high level of regulation.

This has come about for two main reasons: historically there have been some significant mistakes which have resulted in a serious injury and on occasions even resulted in death. Whenever this […]

By |August 27th, 2014|Drug Regulation|0 Comments