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
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.