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THE NEW
NORMAL: HOW
COVID-19
BECAME THE
CATALYST FOR
CHANGE
HOW COVID SPREADED:
As of today:
Coronavirus Cases:
689,020,216
Deaths:
6,880,579
Recovered:
661,408,721
Y0 Y1 Y2 Y3 Y4 Y5 Y6 Y6 Y7 Y8 Y9 Y1
0
Pre-clinical Phase 1 Phase 2 Phase 3
Infrastructure
Manufacturing
Approval
Distribution
Pre-clinical
Phase 1
Phase 2
Phase 3
Infrastructure
Manufacturing
Approval
Distribution
Traditional
Vaccine
Development
Timeline
Accelerated
Vaccine
Development
Timeline
At least six COVID-1
9
vaccines have been
rolled out in less than a
year. Vaccine approval
process usually takes
over a decade
2015 2016 2017 2018 2019
20
15
10
5
0
Covid19 Outbreak
2020 2021 2024 2030
150
100
50
0
6.6%
CAGR 1
2.3%
CAGR
Indian pharmaceutical market, (USD billion), 2015-30F
HOW COVID19 ACCELARATED PHARMA GROWTH
of clinical trial experts believe remote and
decentralized trials will continue to be used
post-pandemic.
A survey conducted by McKinsey &
Company found that
Telemedicine Home nursing
Use of wearables and
sensor technologies
Electronic Informed
Consent tools
THESE TECHNOLOGIES INCLUDE:
Use of local Health Care
Providers
Direct-to-patient
Investigational Medicinal
Product
MODERN DATA MANAGEMENT:
Effective data
management
turns data into a
strategic asset for
pharmaceutical
and medical
companies.
Data
standardization
and governance
ensure
consistency,
integrity, and
compliance.
Global collaboration
and initiatives drive
data standardization
and support digital
transformation in
the life sciences
industry.
AI and ML
technologies
enable efficient
data processing
and valuable
insights.
CYBERSECURITY: PROTECTING
SENSITIVE DATA IN THE DIGITAL AGE
Cybersecurity is vital
for protecting sensitive
data and ensuring the
viability of
pharmaceutical and
medical organizations.
Digitization, alignment
with business
strategies, and future
planning are essential
for effective
cybersecurity
implementation.
AI monitoring agents
offer continuous
network security but
require careful
consideration and
monitoring to address
potential
vulnerabilities.
Virtual inspections have become a
valuable tool, providing efficiency
and flexibility in the auditing
process.
Adoption of the right technology
tools ensures effective remote
assessments and access to
objective evidence.
Auditors must remain vigilant and
use additional technologies like
BIM and augmented reality to
validate data integrity.
VIRTUAL INSPECTIONS: ENHANCING EFFICIENCY
AND FLEXIBILITY
COVID-19 REGULATORY IMPACT: ACCELERATED
TECHNOLOGY AND BUSINESS INVESTMENTS
The COVID-19
pandemic has
accelerated the
speed of change
and adoption of new
initiatives in
regulatory activities.
Virtual environments
have enhanced
transparency and
streamlined decision-
making processes.
Regulatory
information
management
priorities focus on
global strategies,
label and variation
management, and
commitment
management.
Businesses and
teams have
progressed through
Crisis Mode,
Recovery, and
Renewal phases,
with a "New Normal"
characterized by
permanent changes
and preserved
efficiencies.
THANK YOU

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Pharma - covid-Final-2.pptx

  • 1. THE NEW NORMAL: HOW COVID-19 BECAME THE CATALYST FOR CHANGE
  • 3. As of today: Coronavirus Cases: 689,020,216 Deaths: 6,880,579 Recovered: 661,408,721
  • 4. Y0 Y1 Y2 Y3 Y4 Y5 Y6 Y6 Y7 Y8 Y9 Y1 0 Pre-clinical Phase 1 Phase 2 Phase 3 Infrastructure Manufacturing Approval Distribution Pre-clinical Phase 1 Phase 2 Phase 3 Infrastructure Manufacturing Approval Distribution Traditional Vaccine Development Timeline Accelerated Vaccine Development Timeline At least six COVID-1 9 vaccines have been rolled out in less than a year. Vaccine approval process usually takes over a decade
  • 5. 2015 2016 2017 2018 2019 20 15 10 5 0 Covid19 Outbreak 2020 2021 2024 2030 150 100 50 0 6.6% CAGR 1 2.3% CAGR Indian pharmaceutical market, (USD billion), 2015-30F HOW COVID19 ACCELARATED PHARMA GROWTH
  • 6. of clinical trial experts believe remote and decentralized trials will continue to be used post-pandemic. A survey conducted by McKinsey & Company found that
  • 7. Telemedicine Home nursing Use of wearables and sensor technologies Electronic Informed Consent tools THESE TECHNOLOGIES INCLUDE: Use of local Health Care Providers Direct-to-patient Investigational Medicinal Product
  • 8. MODERN DATA MANAGEMENT: Effective data management turns data into a strategic asset for pharmaceutical and medical companies. Data standardization and governance ensure consistency, integrity, and compliance. Global collaboration and initiatives drive data standardization and support digital transformation in the life sciences industry. AI and ML technologies enable efficient data processing and valuable insights.
  • 9. CYBERSECURITY: PROTECTING SENSITIVE DATA IN THE DIGITAL AGE Cybersecurity is vital for protecting sensitive data and ensuring the viability of pharmaceutical and medical organizations. Digitization, alignment with business strategies, and future planning are essential for effective cybersecurity implementation. AI monitoring agents offer continuous network security but require careful consideration and monitoring to address potential vulnerabilities.
  • 10. Virtual inspections have become a valuable tool, providing efficiency and flexibility in the auditing process. Adoption of the right technology tools ensures effective remote assessments and access to objective evidence. Auditors must remain vigilant and use additional technologies like BIM and augmented reality to validate data integrity. VIRTUAL INSPECTIONS: ENHANCING EFFICIENCY AND FLEXIBILITY
  • 11. COVID-19 REGULATORY IMPACT: ACCELERATED TECHNOLOGY AND BUSINESS INVESTMENTS The COVID-19 pandemic has accelerated the speed of change and adoption of new initiatives in regulatory activities. Virtual environments have enhanced transparency and streamlined decision- making processes. Regulatory information management priorities focus on global strategies, label and variation management, and commitment management. Businesses and teams have progressed through Crisis Mode, Recovery, and Renewal phases, with a "New Normal" characterized by permanent changes and preserved efficiencies.

Notas del editor

  1. The no of recovered cases were around 7 million which around 50% of the recovery rate and the death rate is nearly 10%