Pharma Marketing and Regulatory Affairs

1 Year.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or Post Graduates or Phd holder, who want to broaden the career skill in drug regulatory affairs can pursue the course. 3rd and final year student also can pursue this program.

Advanced Diploma in Pharma Marketing and Regulatory Affairs course provides comprehensive training on drug regulatory affairs and pharma marketing principles under the single course. 

Pharma Marketing Topics 

Discovery, Development, Market Access, Commercialization

• Drug Development to Commercialization – R&D Process, New Drug Development, Key understanding on New Drug & Generic Drug launching process, innovator biologic and biosimilar, Fundamental understanding on clinical trial terminologies.
• Pharma Market Research, Market Access & Pricing – Introduction to Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Market Access Landscape | Understanding on Pricing and Reimbursement| Market Access Strategic Planning : Steps and Logical Sequencing for Market Access Strategy Development | Indication Sequencing | Indication Prioritization | Development of Indication Timeline | Indication Matrix | Value Based Indication Prioritization |Market Access Value Dossier | AMCP value dossier preparation | Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD) | Drug Payment Methodologies | Forecasting Models and Techniques | Market Sizing Tools.

Pharma Marketing and branding Strategic Planning

• In depth training on Licensing in pharmaceutical industry – In Licensing Vs. Out licensing, Co-development, co-marketing, Co-promotion, Reverse Copromotion, distribution licensing etc.
• Basics of advertising, handling of advertising agency. Understanding of advertising concepts.
• Brand logo designing – Practical real-life learning. Trademarking – Brand protection for the brand.
• Marketing Plan and brand plan development. Sectional analysis of the marketing plan. Deciding and promoting brand USP. Brand Promotion Plan and Promotogram development. Sample allocation. CSR initiatives and Campaigns Case based marketing strategy discussion.
• Practical training on visual aid development. Step by step visual development process, understanding various components of visual aid and visual aid detailing story writing.
• Marketing input creation – Artwork development process for LBL, product literature, DHCP letter, catch cover, reminder card etc.
• Packaging design – Components, scientific requirements and designing fundamentals.
• Analytics – MAT, CAGR calculation, Brand potential development, RCPA, market size determination, Sales forecasting.
• Conference management skill development.
• Promotion regulation.
• Celebrity endorsement, Celebrity agreement.

Advertisement and Digital Marketing

• Pharmaceutical Digital Marketing – Online marketplace strategic, mindshare Planning, Digital marketing mix for ethical brands & OTC brands, Content marketing, search marketing, Developing HCP sites, digital marketing strategies for innovator molecule and generic molecule, KOL management, Brand blogs, legal aspects of pharma brand digital advertisement, Adword, PPC, video marketing, linked in, E-detailing, digital survey tools

Sales Management

• Pharma Sales Management training – Selling skill training, Territory management, precall and post call planning, various skill training for executives and managers. Various sales related activities and strategic planning with case stude

International Marketing

• Pharma International Marketing training – pharma export documentations, Understanding of important terminologies, Proforma Invoice, Export Contract, Custom House Agent, Freight Forwarder, Letter of Credit Management, Bank Guarantee – How it works, LC discounting, Packing Lust, Incoterms, Pre shipment certificates, Transport Documents, Airfreight calculation

Drug Regulatory Affairs Topics 

In the area of regulatory affairs, course covers general Drug Regulatory Affairs with practical real life simulation. Therefore, one can get the entire knowledge of Regulatory Affairs. 

• Fundamental to Drug Discovery Development to Commercialization
• Clinical Research – Advance Learning
• IPR strategic planning – Patent, Trademarking. Patent and trademark filing, registration, objection, opposition handling process. Patent Term Extension, Patent Term Restoration.
• Marketing Authorization Process and strategic pathways for pharmaceuticals, Biopharmaceutical products. 
• Generic Drug and Innovator Molecule’s Marketing Authorization Process
• ANDA preparation and filing  – ANDA submission, Para IV filing, first to file. 
• Portfolio Management – case based learning – Training on Loss of Exclusivity Management, Evergreening tools and techniques. Various strategic planning. 
• GMP – GMP training, GMP Audits, 483 observations, warning letter, data integrity, SOP Management, CAPA
• Stability study – Requirements, types of stability study, management of stability studies and requirements.
• Variation Management – Authorization management, regional differences. 
• DMF preparation and filing, SMF preparation and filing
• Drug Dossier Preparation, filing and management of the dossier for different product classes. 
• Advance training on biopharmaceutical – innovator and biosimilar regulatory pathway. 

Here the key features of the course.

• Access the courses 24×7 at your convenience
• Online interactive sessions with the expert Industry faculty
• e-Library and e-pharma dictionary
• Access to 1000’s of real life case studies
• Online assignments & self Assessment Test
• Printed Course Material
• 24/7 Online Support With the Live Chat Facility
• Special On demand Modules
• Secure access to e-module with passwords.
• Flexible online final examination (Computer Based Test by secure mode)
• Our courses can be accessed anytime from anywhere

Benefits of the course

• Certification – Receive a personal certificate to show your subject knowledge on course completion. Most importantly, Course completion and gradation certificate is provided on the completion of the course.
• Affordable – Here in this course, you will be learning regulatory affairs and pharmacovigilance both under single course. Hence, you will get excellent value through our cost-effective prices than purchasing both the course separately.
• Flexibility – This is self paced learning. Hence, you can attend the course at own convenience. This lets you complete the interactive course at your own comfort. Therefore, it saves saves you time through the convenience of online availability.
• Keep Up to Date – You will stay up to date with any legislative changes in regulatory affairs and pharma product management as our training courses are constantly monitored, reviewed and updated periodically. Even the latest regulatory changes are incorporated in the course. Most recently, we have also incorporated digital marketing hands on training as it’s an evolving domain of pharmaceutical brand management.
• Learn from Industry Experts – The course content has been developed to ensure that you get based on practical knowledge about holding and managing pharmaceutical brands.