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:
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.
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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
An increased global demand for some medicines
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.
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D3. Unprecedented times bring unprecedented collaborations
“Unprecedented times bring unprecedented collaborations” is the topic of conversation during Session D3 of the ARCS Summit.
In response to COVID the TGA implemented a wide range of new approaches including:
Priority processing of CTNs
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.
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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.
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.
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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.
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).
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