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<title>RA Discussion Forum</title>
<link>http://www.arcs.com.au/RA-Discussion-Forum.html</link>
<description>Latest posts from the RA Discussion Forum</description>
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	<![CDATA[How do you ensure compliance with changing standards?]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=282&PageID=173]]>
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	<![CDATA[How do sponsors of Australian therapeutic goods ensure compliance with the Therapeutic Goods Act when established standards - TGOs, individual or general monographs – change?
Australian sponsors have taken a range of approaches to ensure dossier compliance with respect to such changes with varying degrees of success. What is your company doing? Wh...]]>
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	<pubDate>
	Tue, 19 Feb 2013 16:11:45 GMT
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	<![CDATA[MRAs and TGA GMP Certificates]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=285&PageID=173]]>
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	<![CDATA[A question received from one of our IAC members: 
I am wondering if anyone else has experienced difficulty with acceptance of  a TGA issued GMP and Mutual Recognition Agreement (MRA) certificates.
My understanding was that the MRA Certificate was, by definition, recognised by all countries that participated in the mutual agreement. However, recen...]]>
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	<pubDate>
	Tue, 19 Feb 2013 16:08:24 GMT
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	<![CDATA[Product Dossiers]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=272&PageID=173]]>
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	<![CDATA[Hello Robyn
The TGA has adopted numerous European Union guidelines that address the extent of information they require for biological products. These are located on their website at http://www.tga.gov.au/industry/pm-euguidelines-adopted-biotechnology.htm. If the link doesn't work, you can find them on www.tga.gov.au by navigating to Industry>Presc...]]>
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	<pubDate>
	Thu, 06 Sep 2012 09:40:17 GMT
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	<![CDATA[Product Dossiers]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=272&PageID=173]]>
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	<![CDATA[Hi all,

I am new to this forum and am currently drafting dossiers relating to biologicals.  Can someone please advise what validation reports are generally expected to be included in a pharmaceutical product dossier?]]>
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	<pubDate>
	Mon, 03 Sep 2012 11:40:06 GMT
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	<![CDATA[TGO 80]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=268&PageID=173]]>
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	<![CDATA[Hi,I'd like ot have feedback from companies regarding how they've been adressing requirements 8(3) of TGO80, especially, can we challenge it (eg. tbalet in a bottle)]]>
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	<pubDate>
	Thu, 26 Jul 2012 10:17:26 GMT
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	<![CDATA[Detailing IVDs on CTNs]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=266&PageID=173]]>
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	<![CDATA[I am a study start-up associate at ICON.

One of the “hot topics” or recent changes we are experiencing in study start-up is the inclusion of in-vitro diagnostics (IVDs) on the CTN form for clinical trials being conducted in Australia. This includes the IVDs provided by overseas Central Laboratories for the routine safety blood and urine safety t...]]>
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	<pubDate>
	Thu, 28 Jun 2012 10:07:18 GMT
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	<![CDATA[Year 10 Student Work Experience]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=255&PageID=173]]>
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	<![CDATA[Dear Industry Regulatory Affairs colleagues, I am enquiring whether your company conducts work experience for Year 10 students who are interested in our industry? This request is sent on behalf of my son and I would appreciate your reply.]]>
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	<pubDate>
	Thu, 19 Jan 2012 13:11:08 GMT
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	<![CDATA[Compay procedures for SAS supply]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=211&PageID=173]]>
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	<![CDATA[For those who supply drugs on SAS, can you please tell me what information you require from customers in addition to the SAS form or the TGA Cat B or 19(5) approval and what procedures do you follow? Specifically, do you check validity of the documentation in terms of validity of the SAS authorisation, dosage, etc and the delivery address for the m...]]>
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	<pubDate>
	Thu, 31 Mar 2011 13:11:47 GMT
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	<![CDATA[Panel to review the transparency of the TGA]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=199&PageID=173]]>
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	<![CDATA[An independent Review Panel has been commissioned by the Australian Government to provide recommendations on improving public access and understanding about the work of Australia's medicines regulator, the Therapeutic Goods Administration (TGA). The Panel is seeking input from the public, industry and the medical profession for the purposes of its ...]]>
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	<pubDate>
	Mon, 24 Jan 2011 15:33:06 GMT
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	<![CDATA[Risk management plans for prescription medicines]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=198&PageID=173]]>
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	<![CDATA[A Risk Management Plan (RMP) is a set of pharmacovigilance activities and interventions designed to identify, characterise and manage risks relating to a medicine. It consists of: •an overview of the safety profile of the medicine •a pharmacovigilance plan •a risk minimisation plan. From 1 April 2009 the TGA requires sponsors of selected prescripti...]]>
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	<pubDate>
	Mon, 24 Jan 2011 15:31:30 GMT
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	<![CDATA[Prescription medicine BPR update newsletter - January 2011]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=197&PageID=173]]>
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	<![CDATA[The Prescription medicine BPR update newsletter (BPR update) reports on progress in the BPR program. Each month, the BPR update will report on the progress of the streamlined submission process. Each quarter, an update will be provided on the PI/CMI project and the AusPAR project.
To read the January Newsletter please visit http://www.tga.gov.au/a...]]>
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	<pubDate>
	Mon, 24 Jan 2011 15:27:17 GMT
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	<![CDATA[TGA releases draft Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products. ]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=193&PageID=173]]>
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	<![CDATA[This is an interesting guidance document although there are a few inconsistencies with other TGA guidances already out. There are also a few points of clarification needed but on the whole this is a good step towards full electronic submissions.

Again, interesting that it gets released at the same time that electronic formats should now only be ...]]>
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	<pubDate>
	Fri, 21 Jan 2011 15:18:43 GMT
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	<![CDATA[TGA releases draft Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products. ]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=193&PageID=173]]>
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	<![CDATA[I think it's a good stepping stone to eCTD.  A learning ground as we creep slowly but surely closer into eCTD land.

Thanks for the link Nick.  Appreciate the information sharing as always!]]>
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	<pubDate>
	Fri, 21 Jan 2011 12:44:03 GMT
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	<![CDATA[TGA releases draft Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products. ]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=193&PageID=173]]>
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	<![CDATA[As the aim is to eventually go with the eCTD I would not prefer to fiddle too much with the NeeS at this point. However, it can be a good experience for anybody who does.]]>
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	<pubDate>
	Thu, 20 Jan 2011 11:06:12 GMT
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	<![CDATA[TGA releases draft Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products. ]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=193&PageID=173]]>
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	<![CDATA[The draft TGA NeeS guidance follows the European TIGES standard including requirements for bookmarks and hyperlinks and text searchable documents. Folder naming conventions are also provided for the Australian Module 1, whilst Modules 2-5 follow the ICH eCTD file naming conventions.

http://www.tga.gov.au/pmeds/pmbpi-submissionnees.htm?goback=%2E...]]>
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	<pubDate>
	Thu, 20 Jan 2011 11:03:23 GMT
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	<![CDATA[TGA Business Process Reform Workshops]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=180&PageID=173]]>
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	<![CDATA[What about small Australian manufacturers who actually develop and register their own products or are at the mercy of contract manufacturters and testing laboratories with no global team behind them for support as is the case with big multi-nationals? Its not always easy to have control or tell the third parties what to do if you are not a signific...]]>
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	<pubDate>
	Fri, 10 Dec 2010 14:08:33 GMT
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	<![CDATA[TGA Business Process Reform Workshops]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=180&PageID=173]]>
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	<![CDATA[There is an anticipated learning curve for any new process. Feedback from sessions held to date indicates generally good intentions to fast track the assessment pathway. The process appears to use a just in time approach where the coordination effort from a global perspective is now a critical imperative.  The use of a global team approach to ensur...]]>
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	<pubDate>
	Mon, 08 Nov 2010 11:52:11 GMT
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	<![CDATA[TGA Business Process Reform Workshops]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=180&PageID=173]]>
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	<![CDATA[The Industry Working Group (IWG)discussed the PPF requirements long and hard.  If you work for a company that routinely submits briefing packages in the EU some months prior to the actual EU submission, the contents of that briefing package are sufficient to address the "Draft Module 2" requirements.  You do not have to provide greater detail or us...]]>
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	<pubDate>
	Thu, 04 Nov 2010 10:27:52 GMT
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	<![CDATA[TGA Business Process Reform Workshops]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=180&PageID=173]]>
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	<![CDATA[I was at the Business Reform Workshop in Sydney yesterday and what I found interesting is that while TGA is requesting a "draft" Module 2 as part of the PPF, this "draft" needs to be very close to the final document. As we usually do the Module 2 as the last piece of work in the whole compilation process this will mean that we will have to have the...]]>
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	<pubDate>
	Thu, 04 Nov 2010 07:44:02 GMT
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	<![CDATA[TGA Business Process Reform Workshops]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=180&PageID=173]]>
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	<![CDATA[ARCS is pleased to support the rollout of the TGA Business Process Reforms workshops.  So far three workshops have been held in Brisbane and Melbourne (last week) with over 140 attending so far.  The biggest attendance will be in Sydney this Wednesday, with over 200 registered.  We believe that the large turnout is indicative of the importance of t...]]>
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	<pubDate>
	Mon, 01 Nov 2010 14:06:14 GMT
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	<![CDATA[Business Process Reform Rollout]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=169&PageID=173]]>
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	<![CDATA[Please note that there are five sessions over 3 days.  One in Brisbane and two each in Sydney and Melbourne.  Just go to training opportunities and type in Regulatory then search and the sessions will come up.]]>
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	<pubDate>
	Wed, 13 Oct 2010 08:05:37 GMT
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	<![CDATA[Business Process Reform Rollout]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=169&PageID=173]]>
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	<![CDATA[Please note that announcements re these meeting in various capitals are imminent.]]>
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	<pubDate>
	Mon, 11 Oct 2010 12:58:01 GMT
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	<![CDATA[Business Process Reform Rollout]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=169&PageID=173]]>
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	<![CDATA[A question to Regulatory Members.  The TGA is planning follow-up training in late October.  What areas do they really need to cover?]]>
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	<pubDate>
	Tue, 21 Sep 2010 13:00:32 GMT
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	<![CDATA[Submission of changes to TGA and Medsafe]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=165&PageID=173]]>
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	<![CDATA[Interesting question and also one that I have struggled with myself. It is a catch 22.From a prescription point of view I have always submitted to TGA first followed my Medsafe as I find Medsafe to be a little bit more pragmatic willing to accept arguments compared to the TGA. But this is just my experience and may vary for others. ]]>
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	<pubDate>
	Fri, 27 Aug 2010 09:16:54 GMT
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	<![CDATA[Suppository Dissolution]]>
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	<![CDATA[http://www.arcs.com.au/forum/forumpost.aspx?ForumTopicID=166&PageID=173]]>
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	<![CDATA[Hi,

I am a nerw member so dont know whether I am doing this right but I am looking for information regarding suppository dissolutions esp. once that are coated. Any help will be appreciated.]]>
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	<pubDate>
	Thu, 26 Aug 2010 10:51:30 GMT
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