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PCPM - Ateneo CCE Diploma in Pharmaceutical Medicine & Management Batch 2

Course Name PCPM - Ateneo CCE Diploma in Pharmaceutical Medicine & Management Batch 2
Schedule April 29, 2017 - September 23, 2017

Saturdays

9:00 am - 6:00 pm

Price: Php 90,000
Description

Pharmaceutical Medicine is the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of the marketing of medicines for the benefit of patients and the health of the community.

In terms of governance, pharmaceutical physicians/ medical & regulatory personnel are accountable for the naturegality and standards, including ethical standards, of their work to their employers, to their professional bodies, and under the law as administered by the national Drug Regulatory Authority.

The Ateneo-PCPM Diploma in Pharmaceutical Medicine and Management consists of seven modules that aim to provide the technical knowledge and skills that will equip the pharmaceutical physicians/ medical and regulatory personnel with a core set of competencies aligned with international standards for the appreciation and/or practice of pharmaceutical medicine, at same time in line with Ateneo’s thrust on nation-building.

Objectives

After the course, you will develop the competencies of the International Federation of Associations of Pharmaceutical Physicians (IFAPP):

1. Understand and apply medical science principles and statistics in the evaluation, development, and discovery of new medicines within the context of regulatory environments;
2. Design, execute clinical trials and prepare manuscripts or reports for publication and regulatory submissions;
3. Interpret effectively the regulatory requirements for the clinical development of a new drug, product life cycle, to ensure its appropriate therapeutic use and proper risk management;
4. Evaluate the choice, application, and analysis of post-authorization surveillance methods to meet national/international agency requirements for proper information and risk minimization to patients and clinical trial subjects;
5. Combine the principles of clinical research and business ethics for the conduct of clinical trials and commercial operations;
6. Appraise the pharmaceutical business activities in the healthcare environment to ensure they remain appropriate, ethical, and legal to keep the welfare of patients and subjects in the promotion of medicines and design of clinical trials; and
7. Able to apply the principles and practice of people management and leadership, effective communication, and interpersonal skills to influence key stakeholders and achieve scientific and business objectives. 

Who should attend

Medical doctors, allied health professionals, and management executives who want to gain competencies in the disciplines involving discovery, development, evaluation, monitoring and medical aspects in marketing of medicines for the benefit of patients and public 

Outline

I. Discovery of Medicines and Early Development
A. Therapeutics in pharmacology
B. Discovery of new medicines
C. Planning and organization
D. Regulation and ethics  
E. Pre-clinical drug development
F. Exploratory clinical development
G. Clinical Pharmacokinetics

II. Clinical Development and Clinical Trials
A. Clinical trial planning and management
B. Clinical trial designs, conduct, and documentation
C. Trial design, hypothesis testing, power
D. Measurement and types of data
E. Data collection and management
F. Types of analysis
G. Interpretation of study design, analysis and results

III. Medicine Regulation  
A. Legal and medicines regulation
B. Good practices, harmonization, CTD, labels, AR reports, drug abuse-dependence
C. Clinical trials, ethics, drug classification

IV. Drug Safety Surveillance
A. Drug safety regulation
B. Drug safety in preclinical phase  
C. Drug safety in clinical trials  
D. Pharmacovigilance
E. Pharmacoepidemiology

V. Ethics and Subject Protection 

VI. Healthcare Marketplace 

VII. Communication and Management
A. Role of medical department

Resource Speakers
Dr. Gloanne C. Adolor

is currently an Assistant Professor at the Ateneo School of Medicine and Public Health where she teaches Medical, Management and Leadership subjects. She is a consultant in Internal Medicine and the Research Chairman of the Department of Internal Medicine at Quezon City General Hospital. She holds clinical practice at the Lung Center of the Philippines. She obtained her BS Pharmacy degree from the University of the Philippines, her MD degree from the University of the East Ramon Magsaysay Memorial Medical Center and trained in Internal Medicine at Quezon City General. Dr. Adolor also has an MBA with a major in Health from the Ateneo Graduate School of Business and is completing her PhD in Leadership (Organization Development) also at Ateneo. Her research interests include intergroup leadership, health economics, social entrepeneurship and counterproductive behavior among middle managers.