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pharmacademy

What do we do?

PharmaIntelligence is a management consulting company providing specialized services to healthcare and pharmaceutical companies and organisations.

Our services are bench-marked against International Pharmaceutical Industry standards and include the following areas:

  1. Quality Management & Assurance
  2. Regulatory Compliance
  3. Scientific Research and Development
  4. Commercial Excellence
  5. Education and Training
  6. Health Economics
  7. Evidence Based Medicine

1. Good Quality Practice (cGxP)

The aim of GxP in the Pharmaceutical Industry is to ensure that products are manufactured that are safe and fit for use, meeting strict quality standards throughout the entire process of production.

The essence of GxP can be distilled down to the 5 Ps.

People
  • Have clear roles and responsibilities.
  • Follow all procedures.
  • Are fully trained and assessed for the work they do.
Procedures
  • Are documented and recorded.
  • Cover all critical processes.
  • Ensure deviations are fully investigated and reported.
Products
  • Have specifications for raw materials, components, intermediate and finished products.
  • Follow methods for manufacture and packing, testing, sampling, status control, stability testing and records.
Premises & Equipment
  • Are designed to allow effective cleaning and prevent cross-contamination.
  • Are ventilated and calibrated, have procedures, schedules and records.
Processes
  • Are clearly defined, consistent and documented.
  • Have critical steps defined.
  • Have robust change control procedures.

Good Quality Practice in the Life Sciences Industry includes

  • Good Manufacturing Practice (cGMP)
  • Good Regulatory Practices (cGRP)
  • Good Clinical Practice (cGCP)
  • Good Laboratory Practice (cGLP)
  • Good Distribution Practice (cGDP)
  • Good Warehousing Practice (cGWP)
  • Good Agricultural Practice (cGAP)
  • Good Pharmacy Practice (cGPP)
  • Good Pharmacovigilance Practices (cGPvP)

PharmaIntelligence Consulting provide the following Quality Assurance
specific services

Quality Management Needs Assessment
  1. Due Diligence on Quality Systems
  2. Gap Analysis and Report Presentation
  3. Facilitate Quality Management Implementation
  1. Site Master File Development
  2. Development of Quality Policy & Objectives
  3. Identify & Optimise current Processes and Procedures
  4. Quality Manual & SOP Development
  1. Internal Self Inspections
  2. Audit Readiness
  3. On-site Support for External Audits
  4. Audit Report interpretation and follow-up
  5. Responding to Audit findings
  6. Drafting of and Implementation of Corrective and Preventative Actions (CAPAs)

2. Regulatory Compliance

Regulatory Compliance in the Life Sciences Industry includes

  • Dossier due diligence
  • Gap analysis
  • Dossier compilation
  • Dossier submission
  • Product registration
  • Product LIfe Cycle Management
  • Post-marketing surveillance

PharmaIntelligence Consulting provide the following Regulatory Affairs specific services

Up to date Regulatory Intelligence
  1. Regulatory Authority announcements and new Guidances
  2. Industry Best Practices
  3. Global trends
  4. New software and technology
  1. CTD Modules 1 – 5
  2. Bioequivalence studies and study reports in generic medicine development
  3. Alternative methods in support of Bioequivalence in generic medicine development
  4. Comparative dissolution studies and study reports
  5. Back-to-back comparability studies in biosimilar development
  6. Determination of bio-analytical comparability in biosimilar development
  1. Alignment of dossier content with current Regulatory Guidance
  2. Identify outstanding data and follow-up
  3. Identify outstanding study reports and follow-up
  1. Compile Regional Specific Reports and Summaries
  2. Complete Score Documents and BTIFs
  3. Develop SmPc and Patient Leaflet
  4. Translate SmPc and Patient Leaflet
  5. Compile and submit hard-copy applications where applicable
  6. Compile and publish eCTD dossiers using up to date validated software solutions
  1. Response to change control
  2. Identify required supportive data
  3. Compile and submit hard-copy applications where applicable
  4. Compile and publish eCTD applications
  5. Dossier version control
  1. Pharmacovigilance SOP writing
  2. Pharmacovigilance process implementation
  3. Market surveillance and Signal Detection
  4. Report signals and follow-up
  5. Feedback to Healthcare Practitioner

3. Scientific Research and Development

Scientific Research and Development in the Life Sciences Industry includes

  • Application of sound Scientific and Pharmaceutical Principles in Research and Development
  • Innovation
  • New technologies
  • Develop new formulations and dosage forms
  • Introduce novel products and services
  • Create new marketing opportunities

PharmaIntelligence Consulting provide the following Scientific Research and Development services

  1. Formulation development
  2. Final dosage form development
  3. Design of safety and efficacy studies
  4. Supply of literature-based safety and efficacy data
  5. Dossier development

4. Commercial Excellence CE

Evolving customer needs and technology are disrupting traditional commercial models and go-to-market strategies are increasingly being challenged.

At PharmaIntelligence we assist Pharmaceutical Companies striving for Commercial Excellence by applying cGxP principles to their commercial models

We apply these principles through the following approach

Commercial Excellence Gap Analysis
  1. Analysis of the macro-environmental (external marketing environment) and include direction and pace of change
  2. Company/Business Unit/Product Specific Due Diligence
  3. Benchmark current commercial model to current best practices
  1. Development of CE Policy & Objectives
  2. Identify & Optimise current Processes and Procedures
  3. Quality Manual & SOP Development
  1. Develop an Internal Self-Assessment model
  2. Identify responsible people
  3. Implementation of actions to ensure adherence

Pharmaceutical
Quality
Systems

The International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use provides for a series of Quality System Guidelines.

Reference:
ich.org/quality-guidelines

African
Pharmaceutical
Industry

The overall aim of the AMRH Programme is to support African countries to improve public health by increasing access to good quality, safe and effective medicines through harmonising medicines regulations, and expediting registration of essential medicines.

Reference:
nepad.org/african-medicines-regulatory-harmonisation-amrh

5. Education and Training

Education and Training in the Life Sciences Industry includes

  • Industry developments and trends
  • Latest pharmaceutical trends and biotechnologies
  • Current requirements for Quality and Regulatory Compliance
  • Product knowledge
  • Clinical applications
  • Sales Force Effectiveness
  • Skills development
  • Capacity building
  • Continuous Professional Development

PharmaIntelligence Academy provide the following Education and Training specific services

Subject matter experts
  1. A highly talented and experienced group of subject matter experts responsible for mapping a learning path and dispensing course material filled with exciting, up-to-date training content
  2. Tailored to meet the training goals of each course
  1. Instructional designer
  2. Course facilitators
  3. Course moderators
  4. Course assessors
  1. Traditional classroom-learning
  2. Blended or hybrid-learning that combines formal classroom learning and online methodologies
  3. Distance learning on a Learning Management System (LMS)
  4. Customer-centric solutions

PharmaIntelligence Academy provide the following training courses

Pharmaceutical Sales representatives

The South African Qualifications Authority (SAQA) accredited Pharmaceutical Sales Representation National Certificate (NQF-5) Course, overseen by the Chemical Industries Education and Training Authority (CHIETA)

The Clinical Investigator Certificate (CLIC) Course provided by FUNDISA African Academy of Medicines Development offers capacity building in planning and management of clinical trials, based on the PharmaTrain syllabus.

The South African Pharmacy Council (SAPC) accredited Dispensing of Medicine by Health Care Professionals (Authorised Prescribers) Course

  1. Allopathic Medicine registration
  2. Complementary Medicine registration
  3. Scientific principles of biological medicine and vaccine development
  4. Biosimilars and biocomparability
  5. Bioavailability & Bioequivalence
  6. Comparative dissolution
  7. Compilation of a SmPC and Patient Information Leaflet
  8. Pharmacovigilance
  9. Good Manufacturing Practice
  1. History of Cannabis
  2. Introduction to Medicinal Cannabis
  3. The Endocannabinoid System
  4. Pharmacology of Cannabis
  5. Methods of Delivery and Dosage of Medicinal Cannabis
  6. Clinical Application & Practical Considerations

White label courses

Pharmaceutical sales representatives
  1. Basic Anatomy, Physiology, Pharmacology, Microbiology and Immunology
  2. Disease entities
  3. Treatment options
  4. Product training
  5. Selling skills
  1. Basic Anatomy, Physiology, Pharmacology, Microbiology, Immunology
  2. Disease entities
  3. Product training
  4. Financial management
  1. Disease entities
  2. Product training
  3. Skills development
    • Telephone etiquette
    • Time management
    • Conflict management
    • Emotional intelligence
    • Customer Care
    • Drug safety
    • CPR

Healthcare Professionals

Evidence Based Decision Making
  1. The Nature of Scientific Evidence
  2. Scientific Research Methods
  3. The Role of the Scientific Experiment
  4. The Role of Statistics in Generating Evidence
  5. Application of Scientific Evidence
  6. Hierarchy of Scientific Evidence
  7. Scientific evidence as language and currency of the Life Sciences world
  8. Bias in Scientific Research
  9. The Key Steps in Evidence-Based Medicine
  10. Scientific Evidence and the Pharmaceutical Industry
  11. Evidence Based Clinical Decision Making
  12. Critical Appraisal of Scientific Publications
  1. Definition of Health Economics
  2. Difference between the health services market and competitive markets
  3. Definition of Pharmacoeconomics
  4. Outcomes Research
  5. Types of pharmacoeconomic analyses
  6. Cost-effectiveness and incremental analysis
  7. Design & Analysis of PE Studies

6. Health Economics

Health economics is concerned with issues related to efficiency, effectiveness, value and behavior in the production and consumption of health and healthcare.

The scope of health economics is encapsulated by dividing the discipline into eight topics:

  1. What is health and what is its value?
  2. What influences health? (other than healthcare)
  3. The demand for healthcare
  4. The supply of healthcare
  5. Micro-economic evaluation at treatment level
  6. Market equilibrium
  7. Evaluation at whole system level
  8. Planning, budgeting and monitoring mechanisms

Demonstrating and optimising value is key in Health Economics.

Value does however mean different things to different healthcare stakeholders (governments, doctors, patients etc) and new expansions beyond the traditional cost-effectiveness analysis is often proposed.

Below is an example of such a framework recently proposed by Garrison et al in 2017.

Each Healthcare Project is different and it is therefore critical to take a customised approach in the identification of:

  1. Healthcare Value
  2. Outcome measurements (metrics to be used)

By taking the customised approach the ‘true value picture’ will be created that will lead to the correct choice of healthcare technology.

At PharmaIntelligence we recognise the above requirement and assist clients to identify:

  1. ‘True Value’ for their project
  2. The most useful Outcome Measurements
  3. The correct Health Technology Options

7. Evidence Based Medicine

For healthcare decision makers, the adoption and implementation of innovations are complex and dynamic processes, requiring strong evidentiary support.

In general, decision-makers consider three key issues when making decisions:

  1. Expected budgetary and operational implications
  2. Expected impact on patients
  3. Equitable access to care


In addition to money, Scientific Data is an important additional currency, used across all settings.

Data generated in various setting is processed into Scientific Evidence that is then used to guide decision making in the following general areas:

  1. Product Research & Development
  2. Product Registration
  3. Product Reimbursement
  4. Product Commercialisation
  5. Product Life Cycle Management


EBM is the process of systematically finding, appraising, and using contemporaneous research findings as the basis for clinical decisions.

Even though scientific evidence is the most reported type of evidence used during decision-making, other forms of evidence, including local data and clinical/professional experience are often used.

With this in mind, the need to understand the “complete value” underscores the need to consider multiple types of evidence as well as important contextual factors.

At PharmaIntelligence, we assist clients to

  1. Make sense of all available Scientific Evidence
  2. Incorporate local data and other contextual factors
  3. Create their own customised Complete Value Picture

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Regulatory Compliance. Quality Control. Scientific Excellence.

PharmaIntelligence is a management consulting company providing specialised services to healthcare and pharmaceutical companies and organisations in South Africa and Sub-Saharan Africa.

We optimise project return and reduce project risk by ensuring Regulatory Compliance, Quality Control and Scientific Excellence.

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Contact Us:

+27 21 808 9494

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info@pharmaintelligence.co.za

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