Pharma Knowledge Management – Certificate Course in Regulatory Affairs

13-14-15th Sept.

PHARMA KNOWLEDGE MANAGEMENT is an institution built on knowledge as we believe “KNOWLEDGE IS POWER”. Knowledge is required at every level for an individual to grow from one level to a higher level. When people grow means that the company is growing.

In todays jet age, although every professional wants to upgrade their skills, there is no time for learning, as every individual company has to achieve their monthly & annual set targets. Keeping this in mind PHARMA
KNOWLEDGE MANAGEMENT has designed FAST TRACK COURSES for pharma professionals in Tech Ops.

PHARMA KNOWLEDGE MANAGEMENT offers “ESSENTIAL PROGRAM IN TECHNICAL & OPERATIONAL MANAGEMENT” a new series of fast track Certificate programs.

Certificate Course in Regulatory Affairs

Day 1

Regulatory Affairs – An overview
Global Pharmaceutical Industry
Regulatory Environment
Role of Regulatory Authorities
Data exclusivity
Data Protection and Data exclusivity
Regulatory and Strategy
Regulatory Applications
Introduction to various types of applications
Submission and Approval Process
USA
EU

Day 2

ICH –Common Technical Document
Introduction to ICH guidelines – CTD
Drug Substance
Drug product
Guidance Documents
Product Development
Specifications
Stability Studies

Day 3

Regulatory Affairs and Product Lifecycle Management
Post Approval Changes/Variations
Renewals
Annual Reports
Case Study

Course Details
• During this course, participants will learn Theoretical Aspects as well as industry knowledge.
• Hands on Training to evaluate how well one can apply this knowledge gained into their present job skills.

Faculty Profile

BHARTI KHANNA, M. Pharm., MBA
Ms. Bharti Khanna is a Pharmacist with two decades of experience in the Pharmaceutical Industry. Her primary area of expertise is in Generic Pharmaceuticals, where she provides Strategic, Regulatory and Scientific Consulting to clients interested in catering to the US, EU, Australia, Canada and other markets. She has extensive experience in Research & Development, Scale-up and Technology Transfer, Manufacturing, Project Management, Global Regulatory Affairs and Compliance, covering all activities from Ideation to Execution of Launch of Drug Products.

Earlier to her current position as a Consultant, Ms. Khanna has worked with leading Indian organizations in several arenas and positions, her latest being Vice-President, Research & Development for Promed Exports Pvt. Ltd, where she was leading the R&D Team and was responsible for entire Product Development until Registration of Products for Global Markets. Her earlier assignments include Ranbaxy, as Director – Project Management and Regulatory Affairs, and Dabur – as Joint Director –
Regulatory Affairs, among others.

Ms. Khanna has also has experience in Manufacturing Operations, and also as a Trainer at several points in her career. She is a regular Speaker on various subjects at National-Level Conferences and has imparted rigorous Training and Mentoring to young professionals in the Regulatory and Compliance arena.

PAYAL SURVE, M. Pharm. (Pharmaceutics)
Ms. Payal Surve has 25 years of Industrial Experience comprising Formulation, Quality, Project Management and Regulatory Affairs function. Her last assignment was in UK, heading Regulatory Affairs of a generic pharmaceutical company actively involved in registrations in Europe and Post Licensing Management.

Her professional career initiated in the field of Formulation Development and merged with the Project Management and Regulatory Affairs field, which has now become her core strength. The technical expertise gained in Formulation Development during her initial career span helped strengthen her foray into Regulatory Affairs, Quality and Project Management. During the course of her career, Ms. Payal Surve has had the opportunity to liaison with various companies/ affiliates in US, Europe, Canada, South Africa and Brazil as part of Regulatory Affairs function, as well as Project Lead and Business Development support. Ms. Surve has actively participated in the various GMP Audits by the leading Regulatory Authorities of various countries (USFDA, UK-MHRA, South Africa – MCC, Brazil-ANVISA, HA-Canada) and also had opportunity to perform Post Audit “Compliance Audit” on behalf of one of the advanced countries.

Ms. Payal Surve is holds a Masters Degree in Pharmaceutics from University Department of Chemical Technology, Mumbai, India. She was one of the four speakers to present a talk on Process Validation in a seminar “COMING TO GRIPS WITH VALIDATION” under the IDMA-APA banner held at Bangalore in April 2000.

She is also a Member of the Indian Pharmaceutical Association and has a Publication “Global Initiatives on Regulatory Harmonization” to her name.