Seminars Conferences and WorkshopsEOIs requested for interest in TGA Meeting Your Obligations workshop

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The Therapeutic Goods Administration (TGA) is currently seeking Expressions of Interest for a potential Meeting Your Obligations workshop to be held in Adelaide in November this year.

As navigating the regulatory maze can be a challenge, especially if you're new to regulation, this free, full-day workshop is aimed at beginners who are unfamiliar with therapeutic goods regulation.

SME Assist is a relatively new service that TGA has launched to assist SMEs, researchers, start-ups and those developing new medicines and medical devices that are unfamiliar with therapeutic goods regulation to help them understand their requirements.

To register your interest, please email Marina Delpin, Program Manager: Researcher Professional Development.

If you are making therapeutic claims about a product or have a product that is likely to be considered a therapeutic good, this full-day workshop will help you understand your responsibilities at different stages of the regulation process.


What will be covered

Part I - Basics

An overview of therapeutic goods regulation, including TGA's role, market authorisation and common terms you will encounter when engaging with us.

Part II - Case studies

Case study analyses that cover requirements and obligations that are common across all types of therapeutic goods, including advertising, adverse events and product recalls. These are followed by a Q&A session with TGA specialists.

Part III - Breakouts

Breakout sessions that focus on different specialty areas, depending upon interest. Options are provided when you register online.

Learning objectives

  1. How and why TGA monitors safety, efficacy and quality of therapeutic goods, and what 'conditions of approval' means and how this applies in practice
  2. What data and information you need to collect, hold and provide to meet your obligations as a sponsor, and how this can vary according to the type of good you are the sponsor for
  3. What other processes and requirements you need to meet, particularly with respect to:
    a. monitoring and reporting to the TGA, such as post-market monitoring requirements, manufacturing quality issues or other obligations associated with your product
    b. any changes in circumstances or other issues associated with you, the manufacture of your product (such as how they relate to licensing and Good Manufacturing Practice) and/or the product itself
    c. advertising, and/or any claims you may make with respect to your product
    d. the role of TGA, including your obligations (and our requirements) around product recalls
  4. Your legal and financial responsibilities, including:
    a. fees and charges; for example, application and evaluation fees or fees for inspections
    b. annual charges for all entries on the ARTG and annual licence charges, including how and where these apply
    c. other legal requirements; for example, those pertaining to product labelling
  5. The variations between sponsor requirements depending on the type of therapeutic good, such as for complementary medicines or different classes of medical devices

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  328. (31 Jan 2018) Help contribute to the research agenda & investment plan for a new Research Network
  329. (24 Jan 2018) Science Pathways 2018 registration now open
  330. (24 Jan 2018) Roadmap to a successful IPO for life sciences companies seminar
  331. (18 Jan 2018) Research Professional online training sessions
  332. (15 Jan 2018) ACSPRI Intensive Short Courses
  333. (21 Nov 2017) Taking the lab to the field - insights gained from in situ measurements of isotopes
  334. (08 Nov 2017) Deep Dive Workshop on Collaboration for Industry Impact
  335. (07 Nov 2017) Research grant opportunites with BreastScreen SA
  336. (31 Oct 2017) 2017 Dean Jaensch Lecture - The Crisis in Australian Democracy
  337. (31 Oct 2017) Research Data & Systems Drop-in Session - November 2017
  338. (31 Oct 2017) Research Grants and Contracts Drop-in Sessions - November 2017
  339. (24 Oct 2017) New ways for finding research funding - update
  340. (19 Oct 2017) Technology Transfer Workshop – Call for Expressions of Interest
  341. (12 Oct 2017) STEM Women Branching Out breakfast with Professor Veena Sahajwalla
  342. (10 Oct 2017) MDPP Networking Event - The Future of Surgery
  343. (09 Oct 2017) ACSPRI 2018 summer program now released
  344. (05 Oct 2017) New ways for finding research funding
  345. (04 Oct 2017) Research Data & Systems Drop-in Session - October 2017
  346. (04 Oct 2017) Research Grants and Contracts Drop-in Sessions - October 2017
  347. (28 Sep 2017) 2017 ANZORS-RSA joint conference at the new RAH
  348. (27 Sep 2017) Ignition Series - Getting comfortable being uncomfortable
  349. (22 Sep 2017) Discover more about Australia’s place in space during the 68th International Astronautical Congress
  350. (22 Sep 2017) 2017 Elliott Johnston Memorial Lecture
  351. (21 Sep 2017) Connectome Project Adelaide – “It’s all in the mind”
  352. (21 Sep 2017) Why Every Scientist Should Be on Twitter
  353. (20 Sep 2017) NHMRC New Grant Program Consultation on Peer Review forums
  354. (14 Sep 2017) ARC Grants - Presentation and Discussions by guest speaker Dr Fiona Utley
  355. (13 Sep 2017) ACSPRI Master Class in Mixed Methods Research Design
  356. (13 Sep 2017) Space and Innovation session
  357. (11 Sep 2017) ARC Presentations at Flinders
  358. (05 Sep 2017) 2017 HDR/RHD workshop - Ethics and Integrity in Research with Humans
  359. (30 Aug 2017) Flinders Health Research Week 2017
  360. (30 Aug 2017) 2017 John Chalmers Oration - Professor Anne Kelso
  361. (29 Aug 2017) Research Grants and Contracts Drop-in Sessions - September 2017
  362. (29 Aug 2017) Research Data & Systems Drop-in Session - September 2017
  363. (24 Aug 2017) Need to talk about your research but unsure how?
  364. (24 Aug 2017) 2017 Symposium - Australian Academy of the Humanities
  365. (11 Aug 2017) Network Network Network
  366. (07 Aug 2017) Aiming to revolutionise mental health in Australia
  367. (01 Aug 2017) Research Grants and Contracts Drop-in Sessions - August 2017
  368. (01 Aug 2017) Research Data & Systems Drop-in Session - August 2017
  369. (31 Jul 2017) Postaward process for external research funding
  370. (28 Jul 2017) ComBio2017
  371. (27 Jul 2017) Defence Human Sciences Symposium
  372. (26 Jul 2017) Future-Proofing STEM Industries Summit
  373. (19 Jul 2017) Get Interdisciplinary!
  374. (17 Jul 2017) Why hoverflies?
  375. (13 Jul 2017) MTA - Information Session
  376. (12 Jul 2017) Core Facilities Showcase
  377. (06 Jul 2017) Research Crowdfunding Information Session
  378. (06 Jul 2017) Animal Ethics Group Workshop - July 2017
  379. (28 Jun 2017) Research Grants and Contracts Drop-in Sessions - July 2017
  380. (28 Jun 2017) Research Data & Systems Drop-in Session - July 2017
  381. (23 Jun 2017) The most open and honest grant writing workshop
  382. (07 Jun 2017) What is Advanced Studies?
  383. (24 May 2017) Looking behind the Iron Curtain - Communist? Yes. Spy? Maybe.
  384. (16 May 2017) Research Data & Systems Drop-in Session - June 2017
  385. (15 May 2017) ARC Rejoinders and NHMRC Rebuttals - ‘the Good, the Bad and the Ugly’
  386. (12 May 2017) Constructing your research grant budget - ‘the Nuts and Bolts’
  387. (05 May 2017) Science at the Shine Dome - Tickets still available!
  388. (26 Apr 2017) Research Grants and Contracts Drop-in Sessions - May 2017
  389. (26 Apr 2017) Research Data & Systems Drop-in Session - May 2017
  390. (13 Apr 2017) From the UK to Portugal to Australia, bringing new methodolgies
  391. (12 Apr 2017) Funding Research - drawing on the power of collaboration
  392. (06 Apr 2017) Dr Gianluca Tozzi
  393. (05 Apr 2017) Research Integrity & Misconduct
  394. (28 Mar 2017) Research Data & Systems Drop-in Session - April 2017
  395. (27 Mar 2017) Research Opportunities in Canada
  396. (07 Mar 2017) Show me the money!
  397. (03 Mar 2017) Want to be recognised for your research excellence?
  398. (02 Mar 2017) Environment Matters!
  399. (01 Mar 2017) On the Big Screen – Women in Science
  400. (08 Feb 2017) Eating is Social - the Power of Meals
  401. (23 Dec 2016) National Foundation for Medical Research and Innovation Seminar at Flinders
  402. (23 Dec 2016) Research Data and Systems Drop-In Session - January 2017