​ARCS Summit Round Up - Stream 'D'

Essential updates for regulatory medicine professionals (including the impact of COVID-19)

D1. An update from the Prescription Medicines Authorisation and Manufacturing Quality Branches


Update on the COVID vaccine. Session D1 of today’s ARCS Summit: “An update from the Prescription Medicines Authorisation and Manufacturing Quality Branches” included recent news, posted on the TGA website on 9th October, of the provisional determination to AstraZeneca in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant].

Here’s the link:

https://lnkd.in/gG8kjVW


This means AstraZeneca

is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG).


The TGA is actively monitoring COVID vaccine development

(both in Australia and worldwide) and establishing systems for monitoring the efficacy and safety of COVID vaccines once they reach the market.


With regards COVID changes

the TGA has undertaken a broad range of activities and business process transformation initiatives to assist with ensuring their continued operation – in order to ensure the ongoing supply of quality medicines, blood and human tissue products from Australian and overseas manufacturers.



CONNECT WITH THE SPEAKERS:
Jenny Hantzinikolas
Elizabeth Santolin
Robert Stringer



D2. Medicines shortage: COVID-19 and beyond


COVID has resulted in medicines shortages and supply chain challenges. In this afternoon’s ARCS Summit D2 session the topic being discussed is: “Medicines shortage: COVID-19 and beyond”. KEY POINTS:


The TGAs Medicine shortages scheme

allows TGA to work with sponsors to mitigate shortages.


The COVID pandemic resulted in:
  • Rapid and marked increases in medicines purchasing

  • Reduced availability and increased cost of air freight

  • Manufacturing shut downs

  • Export restrictions

  • An increased global demand for some medicines


TGA response

included establishing a list of priority medicines; the identification of critical sites; & an assessment of local manufacturing capacity for critical medicines.


Medicine shortage concerns

highlighted limitations in supply chain transparency and the need to improve this.


Timely access to information

(locally and internationally) is critical in mitigating medicine shortages; as is collaboration between industry and regulators. COVID has highlighted a greater need for transparent communication around supply chain issues.


CONNECT TO THE SPEAKERS:
Elizabeth de Somer
Elspeth Kay
Mark Jaggers
Ben Noyen
Marnie Peterson
Simon Higgins



D3. Unprecedented times bring unprecedented collaborations


“Unprecedented times bring unprecedented collaborations” is the topic of conversation during Session D3 of the ARCS Summit.

KEY POINTS:


In response to COVID the TGA implemented a wide range of new approaches including:
  • Emergency exemptions

  • Priority processing of CTNs

  • Rolling submissions

  • Simultaneous reviews

  • 5 times the usual number of s19A approvals to supply an overseas-registered product

  • Implementing dispensing and prescribing controls

  • Modelling demand for ICU medicines

  • Expedited applications for relevant products

  • More scientific advice to new and established sponsors

  • Development of specifications for locally manufactured ventilators

  • The establishment of the TGA COVID Enforcement Taskforce


This required increased international regulatory collaboration:

joint or collaborative product evaluations; aligned evidence and safety requirements; mutual enforcement operations target-ing counterfeit COVID therapeutic goods.


Excellent industry case studies

of regulatory success, in response to COVID, where then presented from GSK and Gilead.


CONNECT TO THE SPEAKERS:
John Skerritt
Carolyn Tucek-Szabo Ph.D,Dip IP Law
Kim Halbert-Pere
Andrew Notley
Amne Alrifai



D4. A journey of labelling reforms – an update and what’s next?


TGA and industry insights on the reform of medicines labelling is the topic of Session D4 at this afternoon's ARCS Summit.

KEY POINTS:


The key drivers of labelling reform were:
  • The requirement for a consistent approach to health information

  • The need to ensure that important information wasn’t obscured

  • Improved safety and quality use of medicines for consumers

  • Reduced medication errors

The key changes included:
  • The improved prominence of active ingredients

  • More substances needing to be declared

  • Changes to the name location

  • Mandatory space for dispensing labels

  • Display of Critical Health information for AUST R medicines

  • The use of the active moiety on the main label


The 4 year transition period

(ending August 2020) allowed sponsors to update labels and use up existing stock.


TGA is currently working on TGO 106 = a standard for data matrix codes

– a first step towards medicine traceability, with the benefits of efficient and targeted recalls; global interoperability; improved inventory management; and authenticity verification.



CONNECT TO THE SPEAKERS:
Jolanta Samoc
Michael Carland
Julie Viatos
Jason Leung
Stephanie Iudica



D5. COVID-19 regulatory managers panel discussion

We are hearing insights from regulatory and recruitment experts on how the way of work has significantly changed over the last 6 months.

KEY POINTS:


Transitioning teams to working remotely required a range of adaptations including:
  • Implementing good processes and structure to make the team effective in the management of time and resources

  • Setting up connectivity forums

  • Setting up group productivity tools


Success in this new environment

requires a culture of trust and accountability. What’s important is “what you deliver and how you behave when you deliver it”.


The working environment

is today more caring and more empathetic, with a focus on balancing productivity with wellness.


There’s been an increase in communication

(group chats, Zoom, informal catch ups) and this has resulted in better connectivity.


In today’s environment regulatory professionals

must embrace flexibility and be adaptable; and use the opportunity to develop additional transferable skills (through online training or proactively identifying opportunities for self-development).


CONNECT TO THE SPEAKERS

Mary Nteris, PhD, GAICD
Jo Turner
Liz Joshi
Helen Critchley
Geraldine Storton