NSW Pharmaceutical Science Group

The NSW Pharmaceutical Science Group was established in 1959 to “promote the dissemination and exchange of scientific and technical knowledge, particularly related to the Pharmaceutical Sciences”.

The Group has pursued this objective by the regular organisation of seminars with a panel of expert presenters. The presentations address specific topics or themes as variously applying to production, quality assurance, laboratory, regulatory and R&D of therapeutic goods.

 

Upcoming Events

Click here to register. 

This webinar is free for members and students with a $10 charge made for non- RACI members.

Registrations close at COB, Monday 12 June.  Owing to webinar setup activities, later registration applications cannot be accepted.

 

Past Events

Expand to view available recordings and presentations

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  • Clinical Trials – Expertises, Resources, Collaborative Partnerships and Product Supply - Wednesday, 5 October 2022
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    Clinical Trials in Australia

    Dr Duncan Macinnis, Director of Stakeholder Engagement (NSW/ACT), MTPConnect


    Clinical Trials in Drug Development

    Judy Bingham, Executive Director, Easington Pty Ltd


    GMP and other documentary requirements and guidelines for APIs and dose form

    David Edmonds, former Principal, CMC Regulatory

    Note – since this seminar TGA has updated its website and some links shown to the TGA website in this presentation may not be valid.


    From Bench to Clinic – Translating a new therapeutic into a commercially viable product for clinical trial

    Prof Paul Young, CEO, AB Initio Pharma

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  • Manufacture and Quality Requirements of NMEs/APIs for Clinical Trials

    Dr Jurgen Lindner, Executive Secretary, APIMAA (Active Pharmaceutical Ingredient Manufacturers’

     Association of Australia)


    Specifications, Manufacture and Quality Requirements of Dose Form and Placebos for Clinical Trials

  • Craig Rogers, Director, Syntro Health

    Note:   

    The TGA presentation is not available to be posted on this website.

    A recording of this webinar, not including the TGA content, may be found here.

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  • Establishing and Maintaining Data Integrity - Tuesday 25 October 2022

  • Data from a computational astrochemist
    Dr Laura McKemmish, Senior Lecturer, School of Chemistry, UNSW

    TGA Requirements
    Gaye Camm, Senior Inspector, Manufacturing and Quality Branch, TGA

    Data integrity – Documentation – Batch documentation SOPs, logs etc
    Trevor Schoerie, Managing Director,  PharmOut

    Data Integrity – equipment
    Seamus Orr, Technical Services Manager, AstraZeneca

    Coding creation and scanning
    Bruce Botta, Packaging Technical Coordinator, Aspen Australia

    The Data Integrity Challenges of Analytical Instrumentation
    Clayton Ross, Business development manager, Shimadzu

    Data Protection
    Ian Ward, Managing Director, CyberPro Pty Ltd

    The TGA presentation is posted on the TGA website.

    A recording of this webinar, not including the TGA content, may be found at ?

     

    •     Hybrid Audits - Thursday 1 December 2022
    Matthew Bugg

    Quality Manager, Australia & New Zealand, BeiGene

    A recording of this webinar may be found at ?




  • PSG NSW Presents Building the RNA Ecosystem July 2022
    Click here to see webinar recording

  • Preservatives and Preservatives efficacy Seminar March 2022
  • Therapeutic Goods Labelling - Data Coding and Serialisation November 2021
    Presenters 1 : Dr Tony Manderson, Director, Scientific Operations Management Section, TGA 
    •   Presenter 2: Catherine Koetz Industry Manager – Healthcare GS1 Australia Ltd 
    •  Presenter 3 : Michael Hadjion, Engineering Manager. Aspen Pharma Australia
    • Presenter 4: Richard Driscoll, Traceability lead, AstraZeneca
    • Presenter 5: Peter Barclay, Head of Department, Pharmacy, Sydney Children's Hospital, Westmead
    • Download Standards Behind Standards Presentation
    • Download Implementation and Operation
    • Download An End User Perspective
    • Download Aggregation and Data Accuracy within Serialised Systems

    • Click here to see part 1 of the webinar recording

    •  Click here to see part 2 of the webinar recording

  • Drug Delivery for the Treatment of Children's Cancer September 2021

    • Presenter : Prof. Maria Kavallaris AM, Founding Director, the Australian Centre for NanoMedicine, UNSW Sydney and Head, Translational Cancer Nanomedicine, Children’s Cancer Institute.

    • Click here to see webinar recording 

  • Delivery system for mRNA Covid 19 vaccine  Virtual Event On Wednesday  February 2021

    • Presenter:- Dr Andrew Geall, CEO RNA Consulting, LLC and Chief Scientific Officer of Precision NanoSystems Inc. (PNI)

      Click here to download presentation 

  • Euclidating Vaccine Formulation Stability May 2021 Webinar
  • Ingredient Supply and Change of Sources for Medicine Manufacture Monday  December 2020

    • Presentation 1 :- ARTG Variations to support market supply: TGA’s experience with prescription medicines during COVID-19

      Presentation 2: Supply Specifications

      David Edmonds, Former Principal CMC Consulting

      Presentation link Supply and specifications DE

       

      Presentation 3 :- 6 Months on – lessons learned and the future - Perspective from a Life Science industry supplier & leader: Merck

      Rebecca Lee, ANZ Managing Director, Merck

      Click here to download presentation 

      Click here to see webinar recording

  • Aspects of the Science of COVID-19 – Treatment Virtual Event On Thursday October 2020

    • 1.) COVID-19: Developing Vaccines at Pandemic Speed

    • ----- ----- Natalie Kahwajy, Senior Pharmacist (Antimicrobial Stewardship), Bankstown-Lidcombe Hospital

    • 2.) COVID-19: Treatment: Dexamethasone

    • ----- Ms Renee Faraj - Senior Regulatory Affairs Associate

    • 3.)COVID-19: Treatment: Remdesimir

    • ----- -----Prof Jan-Willem Alffenaar, Chair of Clinical Pharmacy, The University of Sydney, Faculty of Medicine and Health, School of Pharmacy and Westmead Hospital

      • Recording available here

  • Remote auditing - Impact of Covid-19 restrictions on manufacturers and test laboratories September 2020

    • Webinar moderator and host:              

    • 1.) Remote auditing – from TGA MQB perspective

    • ----- ----- Ms Lynn Talomsin, Senior Inspector/Technical Specialist, Manufacturing Quality Branch, TGA

    • 2.) Remote auditing – from an auditee perspective

    • ----- Ms Melanie Richter, Quality Compliance Specialist, AstraZeneca

    • 3.) Auditing and other GMP experiences in the Covid-19 era – US perspective

    • ----- -----Ms Maxine Fritz, Executive Vice President, Pharmaceutical Services, NSF International

      • Recording available here

      NOTE:- The TGA presentation is unavailable on this site and has yet to be posted on the TGA website.

      Click here to Download AZ Remote Audits (RACI)

      Click here to Download NSF - Consulting Issues during Covid-19

  • Aspects of the Science of COVID-19 (3) - Vaccines  - Virtual Event July 2020

    • Webinar moderator and host:  

    • Mrs Niesha Davis, RACI Pharmaceutical Science Group (NSW) Committee and Learning and Development, Technical Manager, AstraZeneca

    • 1.) COVID-19: Developing Vaccines at Pandemic Speed

    • ----- Prof Trent Munro, Senior Group Leader, The Australian Institute for Bioengineering and Nanotechnology

    • 2.) Steps for vectored vaccines as solutions to rapid development of vaccines

    • ----- Dr Paul Howley, Managing Director, Vaxmed Pty Ltd

      • Recording available here


  • Aspects of the Science of COVID-19 (1) Virtual Event  May 2020

    • 1.) Medicinal Chemistry - How do antiviral drugs work? Are there any antiviral drugs for COVID-19?

    • -----  Dr Derek Lowe, Director in Chemical Biology Therapeutics, Novartis Institutes for BioMedical Research

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      2.)Photochemistry of nucleic acids - Why does UV exposure destroy COVID-19

    • ---- A/Prof Tak Kee, Department of Chemistry, University of Adelaide

      Recording available here


  • How is the Pharmaceutical sector dealing with COVID-19  Virtual Event  April 2020

    • 1.) Laboratory perspective.   -----  Alan Doughty, CEO Chemika

      2.)Perspective from a Life Science industry supplier & leader: Merck. ---- Rebecca Lee, ANZ Managing Director, Merck

      3.) Medicine manufacturer’s Perspective.  ---- Gary Lay, Procurement manager, AstraZeneca

      • Recording available here

Schedule

Committee

Position
Chair - Mr Scott Colbourne
Secretary - Mr Scott Colbourne
Treasurer - Mr David Edmonds
Committee Member - Mrs Niesha Davis
Committee Member - Ms Ivon Diaz
Committee Member - Ms Annette Fordham
Committee Member - Dr William Glover
Committee Member - Dr Chen Lim
Committee Member - Dr Jurgen Lindner
Committee Member - Mr Denis Moore
Committee Member - Mrs Noor Salman Qamar
Committee Member - Mr Gonzalo Verges
Committee Member - Dr Nial Wheate
Committee Member - Mrs Colleen Wood

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Article: Regulatory and Other Requirements in Drug Development

  

David Edmonds, December 2019.

 

This article describes how, in conjunction with good and comprehensive science, a knowledge of TGA/Regulatory requirements and guidelines at the earliest stages of drug discovery and development should enhance the quality of the drug development.

 

The article can be downloaded here.