5. The common objective of all pharmaceutical
companies is to discover, develop and market
safe, efficacious and cost-effective medicines that
will bring benefits to patients, health care
professionals and consumers and result in
profitable returns to the company.
6. When developing a potential new pharmaceutical
compound, the primary objectives are to demonstrate
that under the conditions of therapy, the potential
new drug is of constant chemical quality, is effective
in a significant proportion of patients and is safe.
9. Phases of the clinical programme
Humans exposed: 30–50
Humans exposed: several hundred to several thousand
It is used to collect adverse event data from a large patient
10. Type of trial : Therapeutic use
Purpose of trial
• Refine understanding of benefit–risk relationship
in general or special populations and/or
• Identify less common adverse reactions
• Refine dosing recommendations
Clinical trials Phase IV
11. • General information
• Signature page
• Background information
• Trial design
• Selection and withdrawal of subjects
• Treatment of subjects
• Assessment of efficacy
• Assessment of safety
• Quality control and quality assurance
• Ethics and regulatory aspects
• Data handling and record keeping
• Publication policy
The main contents of the protocol (ICH
GCP section 6)
12. ADRs may be classified by cause and severity.
• Type A: Augmented pharmacologic effects - dose dependent and
– Side Effects
• Type B: Bizarre effects (or idiosyncratic) - dose independent and
• Type C: Chronic effects
• Type D: Delayed effects
• Type E: End-of-treatment effects
• Type F: Failure of therapy
• Type G: Genetic reactions
Types of adverse drug reaction
14. • Act as the medical conscience of the company
• Ensure adherence to relevant legal requirements and
• Provide a medical perspective to product development
• Provide the medical input to the servicing and support of
marketed products throughout their life cycle
• Provide general as well as specialized medical expertise.
• Act as the company’s expert interface with all sectors of the
medical profession as well as other external stakeholders
(e.g. regulatory authorities, press, health technology
Role of the medical department
16. Key players from the medical department are likely to be as
• Pharmaceutical physicians
• Clinical research scientists
• Statisticians and data managers
• Medical information scientists
• Scientific advisers
• Regulatory executives
• Drug safety/pharmacovigilance scientists; and
• Pharmacoeconomics advisers.
Key players from the medical
20. • Clinical Research
• Medical Services support
• Statistics Management
• Issues Management
• The pharmaco-economics advise
• Support to MSLs
Responsibilities of a Global Manager
21. • To provide clinical
research support in all
aspects of clinical trials
from planning, design,
• To design study protocol
that describes, in detail,
the plan for conducting
the clinical study.
22. • Effective handling of all information’s relating to drug safety.
• Timely processing of spontaneously reported suspected adverse
drug reactions relating to marketed products, as well as adverse
events reported in clinical trials of both pre-licensed drugs and
marketed product in accordance with current International
Conference on Harmonization (ICH) guidelines (ICH E2C)
• To ensure that all staff in the company are trained on adverse event
reporting guidelines and the recognition of potential safety
information and concerns relating to the company’s products.
23. Support on advertising and POS
• Provide support on scientific
services, advertisement and
other point of sales material.
(Required by Article 13 of
Directive 92/28/EEC (on
advertising) of the Council of the
Medical Services support
24. Support to business development
• In addition to above provide support to business
development on new products development.
Support to Marketing for new launches
• To provide support as a ‘scientific adviser’, as a
specialized information support to a product or therapy
area within the company which could help in launching
products in new therapeutic areas.
Medical Services support
25. • To provide advice on patient numbers and data analysis
as it is essential to endow with a sound statistical
rationale behind a clinical research project if it is to stand
up to scrutiny by regulatory agencies and ethics
• To provide statistical data to be used in support of
26. • Ensuring the accuracy and scientific quality of medical
information needed by both internal and external
• Provide brand-related input into therapeutic area and
disease area in line with company strategy.
27. • With health care costs rising, it is necessary to provide
evidence of effectiveness of the medication and economic
measurements of the benefits that a new drug can provide.
Such comparisons will need to include not only
measurements against competitor drugs, but also against
other medical interventions.
• In line with above should provide timely input on pharmaco-
economics on a new product. (With the guidelines provided by
National Institute for Health and Clinical Excellence (NICE),
the Scottish Medicines Consortium (SMC) and other related
28. The MSL Program
• Mission: Medical Science Liaisons partner
with clinicians through medical education
to further the understanding of the
treatment of different diseases.
• MSLs provide educational-based activities
to increase awareness and enhance
accrual into selected clinical trials.
Medical Science Liaisons ( MSL
29. 1. Medical Expert (ME) Advocacy Development
• Identify and collaborate with Key Opinion Leaders (KOLs), therapeutic thought
leaders and members of the scientific community
• ME relationship management
• Facilitate and maintain scientific dialogue
2. Clinical Trial Support
• Provide on MSL priority projects research site recommendations and
educational activities to support study accrual
• Increase awareness of Herbion clinical research and trial program.
• Identify Investigator Initiated Trials (IIT), Investigator Initiated Research
Programs (IIRP) and Third Party Sponsored (TPS) Studies
Key Roles and Responsibilities
30. 3. Medical Education
• Educate ME on novel and emerging data.
• Provide scientific information to head office on
medically relevant business critical issues.
• Provide medical education to our sales team at location.
4. Scientific Services
• Provide value added scientific services to ME upon their
• Scientific exchange with internal colleagues seeking
external insight to shape companies commercial and
Key Roles and Responsibilities (cont)
31. 5. Scientific Projects
• Implement added value scientific projects according to corporate global
• Alert customers to opportunities (e.g. speaker’s events, clinical studies) that will
allow them to develop professionally.
• Identify, seek and establish connections in the medical community.
• Touch multiple people at customer sites to open more communication channels.
• Participate in scientific groups or societies outside company to establish diverse
networks. Participation should be consistent with company guidelines.
Key Roles and Responsibilities (cont)
33. • Training and Development helps in optimizing the
utilization of human resource that further helps the
employee to achieve the organizational goals as well as
their individual goals.
Training and Development
34. • Productivity – Training and Development helps in increasing the productivity of the
employees that helps the organization further to achieve its long-term goal.
• Team spirit – Training and Development helps in inculcating the sense of team
work, team spirit, and inter-team collaborations. It helps in inculcating the zeal to
learn within the employees.
• Organization Culture – Training and Development helps to develop and improve
the organizational health culture and effectiveness. It helps in creating the learning
culture within the organization.
• Organization Climate – Training and Development helps building the positive
perception and feeling about the organization. The employees get these feelings from
leaders, subordinates, and peers.
• Quality – Training and Development helps in improving upon the quality of work and
• Healthy work environment – Training and Development helps in creating the
healthy working environment. It helps to build good employee, relationship so that
individual goals aligns with organizational goal.
Importance of Training and Development
35. Responsibilities related to Medical Trainings:
• To conduct need assessment (where applicable) regarding medical education and
try to fulfill gaps before and after the training.
• To conduct basis training courses for sales team.
• To conduct basis training courses for our head office teams especially for
marketing and business development departments.
• To conduct leadership development programs along with sales training team.
• To ensure refresher trainings regularly and on need basis.
Training and Development