Pharma Product Management 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 Product Management and Regulatory Affairs course provides comprehensive training on both the domain  under the single course. 

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. 

Drug Regulatory Affairs Topics 

• 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. 

Pharma Product Management Topics

The course has been designed and tailored specifically to the needs of pharma product management learning from practical point of view. Here are the content which is covered under the course.

• R&D Process, New Drug Development, Key understanding on New Drug & Generic Drug launching process, Handling of patent and exclusivity
• Fundamental of product management – Career in PMT, understanding of PMT JOB function and classification of Doctors.
• In Depth practical marketing orientation for the pharma product manager, Market Research, Consumer Behaviour and Brand Adoption Process, Product Lifecycle Management, Segmentation, Targeting and Positioning, Pricing, Logistics, Distribution Channel Management, Promotion management process, Setting and quantifying Promotional objectives, promotional budget setting – tools and techniques. Brand recall, brand recognition, top of mind recall.
• Basics of advertising, handling of advertising agencies.
• 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.
• Promotogram development.
• Handling of cycle meetings.
• Sample allocation. CSR initiatives.
• Case based 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.
• Fundamental understanding on clinical trial terminologies.
• 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, Edetailing, digital survey tools

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 pharma product management 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.