Must know things if working in Pharma Industry.

1. Must know things if working
in Pharma Industry: Secret
for Customer Success
Click on the next slides to learn more….

2. Secret 1: Knowing pharma Industry

3. • Before starting, let us understand the
Pharma Industry.
The pharmaceutical industry discovers,
develops, produces, and markets
pharmaceutical drugs for use
as medications to be administered
to patients (or self-administered), with
the aim to cure and prevent diseases or
alleviate symptoms
In the next slide, you will see various
phases in drug discovery.

4. Phases of Drug
Discovery
Discovery and Development: The drug discovery process gets narrowed when
one lead compound is found for a drug candidate, and the process of drug
development starts
Preclinical Research: Preclinical Trials test the new drug on non-human
subjects for efficacy, toxicity, and pharmacokinetic (PK) information.
Clinical Development: Once preclinical research is complete, researchers
move on to clinical drug development, including clinical trials and volunteer
studies to finetune the drug for human use.
FDA Review: At this time, the FDA reviews and approves, or does not approve,
the drug application submitted by the drug development company.
FDA Post-Market Safety Monitoring: Following drug approval and
manufacturing, the FDA requires drug companies to monitor the safety of its
drug using the FDA Adverse Event Reporting System (FAERS) database

5. Drug Discovery Phase
• Step 1: Discovery and Development(Lead
Compound found)
• Step 2: Preclinical Research()
• Step 3: Clinical Development
• Step 4: FDA Review
• Step 5: FDA Post-Market Safety Monitoring.

6. Facts about Drug
Discovery
The complexity in drug development has increased
manifolds over the past 40 years, requiring the preclinical
phase of drug development, investigational new drug
(IND) application, and complete clinical testing before
marketing approval from the FDA. Generally, new drug
applications (NDAs) or biologics license applications (BLA)
are reviewed comprehensively before approval, and then
drug performance is resubmitted to regulatory agencies
for post-marketing studies. The overarching goal is to
bring more efficient and safer treatments to patients as
quickly as possible after a thorough medical evaluation.

7. Secret 2: Check where you are Contributing

8. Now we can easily place
ourselves where we are
contributing and learn
more about the various
Processes used in the
Industry.
This is a Proactive
approach to ensure we
understand our Customers.

9. Secret 3: How Regulatory bodies and
Compliance works

10. • Regulatory compliance is an organization's adherence to
laws, regulations, guidelines, and specifications relevant to
its business processes. Violations of
regulatory compliance often result in legal punishment,
including federal fines.
• GxP is a general abbreviation for the "good practice"
quality guidelines and regulations. The "x" stands for
the various fields, including the pharmaceutical and
food industries.
• Pharmaceutical Quality Assurance is the assurance of
quality requirements for a product or service in the
pharmaceutical industry. Quality assurance aims to
create and maintain customer confidence in the
product, and the goal is to detect defects early or to
prevent them.

11. • GxP Regulations

12. Secret 4: Innovative Ideas for Process
Improvement

13. • Always find a way how you can improve the
Processes Leveraging data analytics, AI, and
machine learning.
• Digitalising the Laboratory like Integrating the
Software with Instruments, and different
Sources(to capture the information) will
minimize the Human Errors.

14. Thank you for reading this.