New Jersey 732.770.4100

 Drug Safety Workshops

Drug Development Process and Drug Safety

Workshop Topic   Drug Development Process and Drug Safety
Domain Drug Safety Professional Workshop Series 1
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain Learn about the fundamentals of drug development process and drug safety.
Gain an understanding of drug safety departmental workflow in pharmaceutical company and CRO.
Career Pathway Drug Safety Specialist and all the roles in Pharmacovigillance
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety Associate
/Specialist, Safety Data Specialists, Medical Reviewers, Medical Record
Extractors, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance from any
life science and Health care background including but not limited to:
Nurse, Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science

Roles of Drug Safety Professionals

Workshop Topic   Roles of Drug Safety Professionals
Domain Drug Safety Professional Workshop Series 2
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain Monitoring, evaluating and communicating drug safety is a public-health
activity with profound implication that depends on collective responsibilities
of parties consumers, health professionals, researchers, academia, media,
pharmaceutical industry-working together. This course will educate the details
on responsibilities of the drug safety professional and the different areas in
pharmaceuticals where safety input is required.
Career Pathway Drug Safety Specialist and all the roles in Pharmacovigillance
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety
Associate/Specialist, Safety Data Specialists, Medical Reviewers, Medical Record
Extractors, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance
from any life science and Health care background including but not limited to:
Nurse, Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science

ICH, FDA and EMEA guidelines for drug safety

Workshop Topic   ICH, FDA and EMEA guidelines for drug safety
Domain Drug Safety Professional Workshop Series 3
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain The theme of the drug safety is based on these regulatory guidelines.
This course will address the important aspects of the ICH, FDA and EMEA
guideline to implement pharmacovigilance process and an effective approach for adverse event monitoring.
Career Pathway Drug Safety Specialist and all the roles in Pharmacovigillance
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety
Associate/Specialist, Safety Data Specialists, Medical Reviewers, Medical Record
Extractors, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance from
any life science and Health care background including but not limited to: Nurse,
Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science

Sources of ICSR (Individual Case Safety Reports)

Workshop Topic   Sources of ICSR (Individual Case Safety Reports)
Domain Drug Safety Professional Workshop Series 4
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain Triage is the primary important step of the case assessment. This
topic will educate key elements and strategies of Triage including: What are
the regulatory timelines, how to assess the case and how to determine the
case priorities in processing and certain speciifc case scenarios.
Career Pathway Drug Safety Specialist and all the roles in Pharmacovigillance
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety
Associate/Specialist, Safety Data Specialists, Medical Reviewers,
Medical Record Extractors, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance from
any life science and Health care background including but not limited to: Nurse,
Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science

Case Processing

Workshop Topic   Case Processing
Domain Drug Safety Professional Workshop Series 5
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain Learn about the data entry to prepare an Individual case safety report and
preparing the narrative. Gain an understanding on different screen/modules
of the safety database for data entry, duplicate search, creating case in to database and MedDRA and WHO-drug dictionary coding.
Career Pathway Drug Safety Specialist and all the roles in Pharmacovigillance
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety
Associate/Specialist, Safety Data Specialists, Medical Reviewers, Medical Record
Extractors, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance from any life
science and Health care background including but not limited to: Nurse, Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science

Medical Review/ Case Review

Workshop Topic   Medical Review/ Case Review
Domain Drug Safety Professional Workshop Series 6
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain Learn about what all to review in an individual Case to see if it is
completed. Understand all the necessary elements in a case which are required to complete a case. Responsibilites of a Medical reviewer.
Career Pathway Drug Safety Specialist/ Medical Reviewer
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety
Associate/Specialist,Safety Data Specialists, Medical Reviewers, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance from any
life science and Health care background including but not limited to: Nurse, Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science

Medical Records Extraction

Workshop Topic   Medical Records Extraction
Domain Drug Safety Professional Workshop Series 7
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain Learn about what all relevant information you need to extract form
over 1000 pages of medical records. Understand all the necessary information in
medical records needed to be extracted into a standard form. Responsibilites of a Medical record extractor.
Career Pathway Drug Safety Specialist/ Medical Record Extractor
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety Associate
/Specialist, Safety Data Specialists, Medical Record Extractors, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance from any
life science and Health care background including but not limited to: Nurse, Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science

Sources of ICSR (Individual Case Safety Reports)

Workshop Topic   Sources of ICSR (Individual Case Safety Reports)
Domain Drug Safety Professional Workshop Series 8
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain Learn about all different sourses from where a Adverse event case
can be reported. Understand all different kinds of source documents. Learn about what all to look for in a source document to identify an AE.
Career Pathway Drug Safety Specialist and all the roles in Pharmacovigillance
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety Associate
/Specialist, Safety Data Specialists, Medical Reviewers, Medical Record Extractors, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance from any
life science and Health care background including but not limited to: Nurse, Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science

Periodic Safety Update Reports

Workshop Topic   Periodic Safety Update Reports
Domain Drug Safety Professional Workshop Series 9
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies, assignments
and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain Learn about all different types of Periodic safety update reports, Why are they
necessary, also learna bout what all data you need to include in a Periodic safety update reports.
Career Pathway Drug Safety Specialist and all the roles in Pharmacovigillance
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety Associate/
Specialist, Safety Data Specialists, Medical Reviewers, Medical Record Extractors, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance from any
life science and Health care background including but not limited to: Nurse, Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science

SOP Developments and updates

Workshop Topic   SOP Developments and updates
Domain Drug Safety Professional Workshop Series 10
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Pharmacovigillance.
What Student will learn/gain Learn about what are SOP's in Pharmacovigillance, Its Importance,
Requirements, How to write a SOP, Difference between SOP and Guidelines, How to implement, monitor and Update an SOP etc
Career Pathway Drug Safety Specialist and all the roles in Pharmacovigillance
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Drug Safety Associate/
Specialist, Safety Data Specialists, Medical Reviewers, Medical Record Extractors, Pharmacovigillance associates and any other roles related to drug safety.
Prerequisite Prospective candidates for Drug safety and Pharmacovigilance from any life
science and Health care background including but not limited to: Nurse, Pharmacist, Biotech, Pharmaceutical Science, Allied Health Science


© 2017   |   Qtech-Sol Professional Development Center LLC.   |   All rights reserved