BioMelbourne Network
Progressing BioIndustry
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8th February BioWorkshop
New Regulations for Biologics
Are you prepared for the new regulations for biologics? Event Description
| When: |
Wednesday 8th February 8:45am registration 9:00am workshop 12:30pm close, followed by a light lunch |
|---|---|
| Where: |
BioMelbourne Network 25 Flinders Lane Melbourne |
| Speakers: |
Ms Penny Field (Principal, Bioregulatory Consulting) Associate Professor Dianne Jackson-Matthews (Director of Regulatory Affairs, ERA Consulting Australia) |
| Price: |
$350.00 members $800.00 non-members Prices include GST Cancellation Policy Full refund given up to 21 days prior to the event. Half refund given up to 14 days prior to the event. No refunds within 14 days of the event. |
| RSVP: | Friday 3rd February, 2012 |
About This Event
Human cell and tissue therapies offer a range of novel therapeutic options for patients with life threatening or chronic debilitating conditions. Examples of such therapies cover a diverse range of areas from heart valves to cancer-cell vaccines and there are an increasing number of innovative approaches being developed ranging from prosthetic and restorative to therapeutic. Traditionally these therapies have been considered as medical practice and have often fallen outside Australian regulations as specified by the Therapeutic Goods Administration (TGA) until this year.
Within Australia, human cell and tissue therapies (HCTs) have recently been brought under the Biologicals Regulatory Framework. This system came into effect on 31 May 2011 with a 3 year transition period. For new products it is necessary to comply with the new regulations prior to marketing. For products which are already available there is an incentive to lodge a registration application prior to 30 November 2012.
This BioWorkshop will:
• Provide an overview of the new Biological Regulatory Framework and discuss which therapies are and are not included under this regulation
• Discuss the type of data that will need to be included in the dossier for submission to the TGA
• Provide case studies on a range of cell and tissue therapies and illustrate the data that may be applicable for Class II and III products
• Industry case study on the work that is been undertaken in preparation for compliance with Biologicals Regulatory Framework.
Event Location
BioMelbourne Network
Milton House
25 Flinders Lane
Melbourne
