Organizational Plan of Pharmaceutical Company

Quiz
Name :Nooresehar
Roll:70128972.
Section :2B
“Organizational design of pharmaceutical Company “
Organizational design is a process that defines a company's leadership practices and hierarchy. A
company's organizational design can affect its workplace culture, efficiency, workplace relationships
and production value.
Types:
The four types of organizational structures are functional, divisional, flatarchy, and matrix
structures.
Oraganizational design of pharmaceutical company.
Once products have been approved for large-scale distribution, Pharmaceutical companies scale-up
manufacturing and align themselves with intermediaries to sell the drug through various channels
(direct-to-consumer or through distribution channels such as pharmacies and hospitals).
These companies study the diseases, research, and invent new drugs/medicines for the diseases.
Drug discovery and marketing are major expenses for these companies. The pharmaceutical
companies require medical data and reports of patients for researching and discovering new drugs.
Pharmaceuticals:
Pharmaceutical companies handle the research, production and delivery of
pharmaceutical drugs to healthcare service providers (physicians, pharmacies,
hospitals, etc.) and consumers. Pharmaceutical products must go through extensive
research and testing (i.e., Research & Development), as well as follow regulations and
obtain approval from government entities such as the Food and Drug Administration
(FDA) before the products can reach its targeted market. Once products have been
approved for large-scale distribution, Pharmaceutical companies scale-up
manufacturing and align themselves with intermediaries to sell the drug through
various channels (direct-to-consumer or through distribution channels such as
pharmacies and hospitals).
Common Pharmaceuticals job titles: Chief Executive Officer (CEO), Chief Operating
Officer (COO), Chief Financial Officer (CFO), Chief Medical Officer (CMO).
Research & Development

The Research and Development function is responsible for creating new
medications and installing them in the disease-fighting arsenal of physicians. The
process begins with "discovery," during which time researchers identify new
candidates from a large library of chemical compounds. Thousands of such
candidates are selected using modern computerized tools. After the candidates
have been selected, they are tested for their ability to move through the body and
interact with the desired pathology. Researchers then optimize the candidates by
altering their chemical structures to increase their medicinal effects and to
decrease their side effects. A phase of tests determines whether the drug is safe
enough for human testing. By the end of these steps, only a handful of candidate
drugs will remain. These are entered into clinical trials, which is the final and
longest step.
Clinical Trials:
The testing phase of a new drug is a lengthy and expensive part of research and
development. The Food and Drug Administration (FDA) demands that candidate
pharmaceuticals pass through a three-phase process of human trials to demonstrate
safety and baseline efficacy. The first two phases involve only small sample groups of
test patients. The third phase involves a sample size of thousands of patients and
carries huge costs. Generally, Phase III trials need to demonstrate that a drug meets
the necessary efficacy requirements with a 95 percent statistical certainty.
Common Clinical Trials job titles: Research Investigator, Clinical Trials Research
Associate, Clinical Research Coordinator, Clinical Cell Therapy Tech
Drug Discovery:
Drug discovery is the process by which new disease or sickness-fighting compounds
are screened and identified. This is the first step in new drug development. During this
phase, compounds are identified and tested using criteria such as efficacy, stability and
bioavailability.
Common Drug Discovery job titles: Drug Discovery Scientist, Immunology Scientific
Investigator, Research Scientist
New Drug Approval:

New drug approval from various regulatory bodies (such as the FDA) is the next step in
bringing a drug to market, following a successful round of clinical trials. The regulators
review rigorous statistical analysis and test results produced during the clinical trial
phases. Some drugs may be "fast-tracked" if they treat a serious condition that does
not currently have many viable treatment options. After a new drug has been
approved, it is ready to move into the manufacturing process.
Common New Drug Approval job titles: Regulatory Specialist, Regulatory Affairs
Associate, Clinical Regulatory Associate
Post-Approval Research & Monitoring:
During post-approval research & monitoring, Pharmaceutical companies continue to collect data on
the efficacy and use of a drug after it is approved and manufactured. They monitor factors such as
safety, long-term side effects and potential secondary uses for the drug. Continued research can
identify additional clinical value (new methods of delivery, combination of treatments, new uses,
patient targeting, etc.). for drugs that have already been approved.
Pharmaceutical Manufacturing:
The Pharmaceutical Manufacturing function is responsible for producing drugs on an
industrial scale following testing (clinical trials) and regulatory approval. The process of
manufacturing pharmaceutical products includes many unique components, including
chromatography, milling, coating, granulation and pressing. Other facets of the
pharmaceutical production process, such as batch integrity testing, quality assurance
and facility maintenance, are common to other manufacturing operations. In some
cases, pharmaceutical manufacturing groups may produce active pharmaceutical
ingredients (APIs), while other manufacturers might purchase APIs in bulk from a third
party and prepare them for consumption by adding certain compounds, binders
and/or fillers.
Common Pharmaceutical Manufacturing job titles: Production Chemist, Pharmaceutical

Process Engineer, Pharmaceutical Manufacturing Engineer, Biotech Production
Specialist
Product Education & Compliance:

The Product Compliance function is responsible for the final licensing of a drug (after
clinical trials) and the subsequent labeling, education and information management
related to that product. They ensure that products are labeled in accordance with
requirements set forth by the Food and Drug Administration (FDA) and fact-check
marketing/promotional materials that are used to market the drug to physicians and
potential patients. In some cases, the product compliance group may audit company
operations (manufacturing, drug testing, etc.) to ensure that all operations are in
compliance with industry regulations.
Common Product Education & Compliance job titles: Medical Information Specialist,
Product Compliant Specialist, Medical Writer, Medical Editor, Clinical Operations
Document Specialist
Patient Assistance Programs (PAPS):

Patient Assistance Programs (PAPs) are initiatives funded by pharmaceutical companies
to distribute free or reduced-rate medicines to people with low to moderate- income or
who are underinsured. The eligibility requirements for these programs may vary; some
programs demand that the patient be uninsured, while others require that certain
income levels are met. PAPs have been in existence since the 1990s, and have helped
roughly 7 million patients since 2005, according to statistics kept by the Partnership for
Prescription Assistance.
Common Patient Assistance Programs (PAPS) job titles: Financial Assistance

Representative, Patient Assistance Counselor, Patient Assistance Coordinator, Patient
Advocate.

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Quiz

“Organizational design of pharmaceutical Company “

Oraganizational design of pharmaceutical company.

Research & Development

New Drug Approval:

Common Pharmaceutical Manufacturing job titles: Production Chemist, Pharmaceutical

Product Education & Compliance:

Patient Assistance Programs (PAPS):

Common Patient Assistance Programs (PAPS) job titles: Financial Assistance

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