Thursday, 26 April 2018

SCIENTIFIC AND CLINICAL


SCIENTIFIC AND CLINICAL
Important Terminologies:
Ø Medical Device Deals with Treatment, Mitigation, Diagnosis which get the Intended Results by Mechanical, Thermal Means.
Ø Regulations:
·        FDCA: United States Federal Food Drug and Cosmetic Act Regulations
·        CFR: Code of Federal Regulations


Ø  CLASSIFICATIONS:

Ø Medical Device Class with Example:


Ø  MEDICAL DEVICE LIFE CYCLE

Ø GLOBAL REGULATORY BODIES:


 Clinical Trial Phases

·       Pfizer Inc. is an American pharmaceutical conglomerate headquartered in New York City, with its research headquarters in Groton, Connecticut.
·       Pfizer is one of the world's largest pharmaceutical companies.
·       The company develops and produces medicines and vaccines for a wide range of medical disciplines.
·       Medicine in Pfizer:- Its products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol; Lyrica (pregabalin) for neuropathic pain/fibromyalgia; Diflucan (fluconazole), an oral antifungal medication; Zithromax (azithromycin), an antibiotic; Viagra (sildenafil) for erectile dysfunction; and Celebrex/Celebra 
·       Therapeutic Area:  
Ø Immunology :- Immunology is a branch of biology that covers the study of immune systems in all organisms
Ø Oncology :- Oncology is a branch of medicine that deals with the prevention, diagnosis, and treatment of cancer
Ø Cardiology :- Cardiology is a branch of medicine dealing with disorders of the heart as well as parts of the circulatory system
Ø Diabetology:- The study of the diagnosis and treatment of diabetes
Ø Neurology:-  Neurology is a branch of medicine dealing with disorders of the nervous system.
Ø Endocrinology:- Endocrinology is a branch of biology and medicine dealing with the endocrine system, its diseases, and its specific secretions known as hormones.
Ø Vaccines:- Prevnar 13 is based on the scientific foundation of Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the first pneumococcal conjugate vaccine introduced in the U.S. in 2000 by Wyeth, now a part of Pfizer.
Ø Rare Disease
Ø Products for respective therapeutic areas
·       SEGEMENTS:
Ø Human Health
Ø Consumer Products
Ø Animal Care
·       SUBSIDERIES:
Ø Hospira    An American global Pharmaceutical and Medical device Company
Ø Medivation – An American Biopharmaceutical Company
Ø Parke Davis
Ø Anacor – Biopharmaceutical Company
Ø King Pharmaceuticals , Bristol, Tennessee, US
Ø ViiV Healthcare – Pharmaceutical Company, Brentford, UK
Ø Alacer Corp. , California, US
Ø Vicuron Pharmaceuticals, Pennsylvania, US
Ø Pfizer Japan Inc.
Ø Warner-Lambert
Ø Embrox
Ø Up jhon
·       Pfizer Main Locations:
Ø Groton, Connecticut
Ø La Jolla, California (around 1,000 staff, focused on cancer drugs)
Ø South San Francisco, California
Ø Cambridge, Massachusetts
Ø Kalamazoo, Michigan
Ø St. Louis, Missouri
Ø Van Buren, AR                                
Ø Foothill Ranch, CA
Ø Irvine, CA                               
Ø San Diego, CA              
Ø Denver, CO         
Ø New Haven, CT
Ø Albany, GA                            
Ø Andover, MA
Ø Cambridge, MA                     
Ø Kalamazoo, MI
Ø Richland, MI                                   
Ø Rochester, MI
Ø Chesterfield, MO                  
Ø St. Louis, MO
Ø Durham, NC                                    
Ø Sanford, NC
Ø Madison, NJ                                    
Ø Parsippany, NJ
Ø Peapack, NJ                                    
Ø New York, NY
Ø Pearl River, NY                                
Ø Rouses Point, NY
Ø Rye Brook, NY                                 
Ø Franklin, OH
Ø Westchester, OH                            
Ø Carlisle, PA
Ø Collegeville, PA                     
Ø Memphis, TN
Ø Richmond, VA                       
Ø Middleton, WI
·       Competitors:
Ø Merck & co
Ø Teva
Ø Ranbaxy
Ø Astra Zeneca
Ø Novartis
Ø Savofi Aventis
Ø Apotex
Ø Jhonson and Jhonson
·       Product Lines:
Ø Pharmaceutical products
ü Atorvastatin (trade name Lipitor)
ü Prevnar
ü Lyrica (pregabalin)
ü Viagra (sildenafil)
ü Norvasc-antihypertensive drug
ü Diflucan
ü Zithromax
ü Zoloft
Ø Consumer healthcare products
ü Advil (ibuprofen)
ü Centrum
ü ChapStick
ü Dimetapp
ü Preparation H
ü Robitussin
·       Requirements:
      Engineering--Project Coordinator-Andover, MA
      Validation Engineer II--Rocky Mount – NC; Lake Forest IL; Andover – MA
      Clinical Trial Associate & Medical Writer – Groton CT
      Clinician & Clinical Study Manager -- La Jolla – CA
      Medical Writer & Pharmacology Associate -- Sanford – NC
      Pharmacology Associate – I, II & Medical Writer-I, II -- Peapack – NJ
      Repeated positions in New Haven – CT
ü Clinical Program Manager
ü Clinical Research Nurse- I, II
ü Medical Assistant – I
ü Medical Lab Technologist – I
ü Clinical Trail Manager
      Repeated positions in Collegeville – PA
ü SAS Programmer
ü Clinical Study Manager
ü Miscellaneous Clinical Roles
      Repeated positions in Chesterfield – MO
ü Medical Writer
ü Miscellaneous Clinical Roles
ü Project manager – II
      Repeated positions in New York, NY
ü Pharmacology Associate
ü Statistician
ü Medical Writer – I, II
ü Clinical Program Manager
ü SAS Programmer
ü Investigator Initiated Research
ü Clinical Research Associate
ü Clinical Data Manager – I, II
ü Safety Surveillance Associate – I, II
ü Miscellaneous Clinical Roles
·       Important TERMS:-
Ø In Vitro
Ø In Vivo
Ø Biological Scientist
Ø Veterinarian




Avijit Mishra 

Scientist | Researcher | Career Counselor