Business, Medical & Scientific Trainer

Based on my education as a doctor, speciality in Pediatrics and being trained in many fields at PfizerI have a vast repertoire in business and medical training programs,

Thought the basis of every traing is the same, each one os "tailor made" to fit the requirements of the trainess and their education level & conprehension of the subject.

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This is an in-depth program that encourages doctors from all specialties and fields to encourage ethical behavior not only with patients, but also amongst doctors themselves.

This program includes:

?Doctor patient interaction
?Doctor- doctor interaction
?Ethical communication
?Speaking with patients relatives when imparting bad news
?Human rights and ethics concerning patients
 

Have Dr. Shireen K. give you more insight into her Training-strengths in 'Ethics'. Mail her now!

Clinical trials are undertaken in both hospital and general practice centers all over the world. Patients receiving new drugs need to be enrolled in trials that are undertaken in the highest standards in order to obtain valid and reproducible data.

GCP (Good Clinical Practices) may be defined as a ?standard by which clinical trials are designed, implemented & reported so there is public assurance that the data are credible, and the rights, integrity & confidentiality of subjects are protected.?

The course includes:

1.Investigators? Responsibilities
?Recruiting study personnel
?Facilities
?Timescale
?Protocol
?Ethics Review Committee
?Obtaining Informal Consent &
Confidentiality
?Trial materials
?Source data verification, archiving and general matters

2.Monitors? Responsibilities
?Creating protocols
?Ensuring the investigators fulfill the obligations of the clinical trials.
?International Committee for Harmonization
?Declaration of Helsinki
?Monitoring tactics
?Data collection and compilation.


Registering a Drug under the Drug Laws of the Ministry of Health (local or international)

?Registering a drug manufactured in the country
?Registering a drug manufactured abroad
?Getting permission for the import of raw material
?Getting permission for the import of unregistered drugs for the use in clinical trials.


Safety & Adverse Event Management

Patients and prescribers expect approved medicines to be "safe and effective." The goal of those who produce and regulate proprietary medicinal products is to ensure that this expectation is met. This requires that clinical trials be planned and performed to provide good evidence that tested medicines are effective and that patients can be reassured that the benefits outweigh the risks, both during the development process and in general use.


1. INTRODUCTION AND OVERVIEW

Terminology and definitions
1.Ethical aspects of clinical trials
2.Overall pharmaco-vigilance/risk management system
3.Collection and proper management of safety data
4.Evaluation of safety data
5.Statistical analysis of safety data
6.Regulatory reporting and communication to others of safety information during clinical trials

2. ETHICAL CONSIDERATIONS FOR CLINICAL TRIAL SAFETY MANAGEMENT

Background - The Stakeholders
1.Patients, Regulatory Authorities and Investigators
2.Data and Safety Monitoring Boards
3.Pharmaceutical Companies and Their Representatives
4.Privacy and Confidentiality of Personal Data
5.Informed Consent
6.Transparency in Availability of Clinical Trial Results

3. GOOD PHARMACOVIGILANCE AND RISK MANAGEMENT PRACTICES: SYSTEMATIC APPROACH TO MANAGING SAFETY DURING CLINICAL DEVELOPMENT

Principles of a Systematic Approach

1.Establishing a procedure, a Multidisciplinary Safety




2.Management Team (SMT), and a project management function
3.Determine background data
4.Ensure accessibility of data
5.Develop a proactive approach
6.Establish timeframes and milestones
7.Decision Making
8.Advisory Bodies

4. COLLECTION AND MANAGEMENT OF SAFETY DATA DURING CLINICAL TRIALS

1.General Principles
2.Causality Assessment
3.Diagnoses vs Signs and Symptoms
4.Adverse Events of Special Interest
5.Laboratory Chemistry Measurements
6.Morbidity and Mortality as Efficacy Endpoints
7.Special Situations

6. STATISTICAL ANALYSIS OF SAFETY DATA IN CLINICAL TRIALS

Uses of Statistics for Clinical Safety Data
Principle of Intention to Treat
Some Key Problems in Safety analyses

7. REGULATORY REPROTING AND OTHER COMMUNICATION OF SAFETY INFORMATION FROM CLINICAL TRIALS

Expedited Reporting from Clinical Trials

Periodic Communication of Safety Information from Clinical Trials
Safety Management Process
 

Have Dr. Shireen K. give you more insight into her Training-strengths in 'Health and Safety'. Mail her now!

This training is focused and designed to improve selling skills and motivate pharmaceutical sales professionals to continuously improve. The program covers the fundamentals of sales and motivational training, and mixes it with sound, time tested common sense.

The training objectives are to increase sales, achievement of personal goals, growth as a person and excellence in your marketplace.

?Sales: Training and motivational sessions address selling as a profession. Sales, selling and service are the life of a business. Selling is a transaction that adds value to the customer and mutual benefit to both seller and buyer.

?Achievement: Success in sales is reaching your goals and becoming the person you are capable of becoming. The best sales people are achievers and love accomplishment.

?Growth: Moving outside the comfort zone to become more creative, develop new skills and improve talents, to live the essence of the entrepreneur. Growth through personal development and becoming greater value in the marketplace.

?Excellence: Be the best in your market. Stand out from competitors through your high level of service, wisdom, common sense and abilities.

Program Goals:

The goals of the program are to provide sales managers and reps with effective sales and motivational training programs and motivate them to improve themselves as sales professionals. This will result in individual goal attainment. Training programs will be interactive and open discussion forums. They will focus on how the customer can be helped and serviced. The sessions are based on trust and honesty, and how selling and personal development can lead to proven results today and in the future.


Sales Training Program Outline:

The following areas are discussed in open discussion, facilitated training sessions with the sales reps. a sales and marketing action plan is developed for the sales team and each individual sales rep. The action plan includes the critical steps needed that enables the sales and marketing training to increased revenues for the sales rep, the team and the organization.


Traits of Successful Sales People
?Everything Begins with Attitude
?Personal Development as a Sales Professional
?Rewards of Personal Development
?Mission Statement and Goal Setting
?How to Implement Personal Goals and Measure Results
?How to Motivate Yourself Every Day
?Organization and Time Management
?Balance of Mental, Emotional, Spiritual and Physical
?The Sales Pipeline
?Objections
?Presentations that Focus on Benefits
?Closing that is Automatic
?How to Add Value to a Customer
?Relationship Building and Trust
?Accessing and Working with Personality Types
?Passion
?How to be Creative and Analytical
?Negotiation Skills
?Communication Skills
?Customer care concepts
?Selling skills

Professional Telephone Selling
?Why is Phone Selling Key to Success
?Review the Unique Characteristics of Phone Selling
?Lead Generation and Prospecting on the Phone
?Objections on the Phone
?How to get an Appointment
?Follow-up on the Phone
How to Build a Telephone Relationship

Sales Management and Leadership
?Team Mission Statements
?How to Hire Exceptional Sales People
?Performance Evaluations
?How to Motivate your Reps
?Team Goal Development
?Sales Contents and Special Incentives
?Teamwork in Sales
 

Have Dr. Shireen K. give you more insight into her Training-strengths in 'Biotechnology and Pharmaceuticals'. Mail her now!