About the Program

Objectives of the Program
  • To provide insights into the global regulatory requirements and strategies for Biosimilars, Eco-pharmacovigilance and generic drug development, including the role of Hatch-Waxman act and Orange book.
  • To outline regulatory standards for Risk-based monitoring and post marketing studies in the US and EU.
  • To enhance understanding of ICH GCP and QMS in clinical research, regulatory affairs pre-approval and post-approval processes, emerging trends in pharmaceutical regulatory affairs, and best practices for eCTD submission preparation and validation, supported by real-world case studies.
Expected Outcome of the Program

Students will understand from an industrial perspective,:

  • They acquire knowledge of the drug development process, including discovery, pre-clinical & clinical trials regulations, regulatory approval, and post-marketing activities.
  • They develop expertise in interpreting and applying global regulatory guidelines (e.g., FDA, EMA, ICH) and acquire skills in preparing regulatory dossiers in formats such as CTD and eCTD.
  • They gain a real-world understanding of Pharmaceutical Regulatory Affairs outside the college setting.

Important Dates

Date 17th Sept 2024 - 21th Sept 2024
Time 09:00 AM onwards
Target Audience PG students and Faculty
Type of program Offline
Venue Library Auditorium

Resource persons

sangamesh

Dr. Sangamesh Purnik

Founder and Director
Thiagrow labs private limited

Founder and Director
Thiagrow labs private limited

mahesh

Dr. Mahesh bk

Visiting Professor
Acharya & BM Reddy College of Pharmacy Bangalore

Visiting Professor
Acharya & BM Reddy College of Pharmacy Bangalore

vanajakshi

Mrs. Vanajakshi M

Centralized Monitoring Lead
Bangalore

Centralized Monitoring Lead
Bangalore

vijayaraghavan

Ms. Sindhu Sundar

Regulatory Senior Specialist
at Merck

Regulatory Senior Specialist
at Merck

venugopal

Mr. Venugopal

Regulatory Affairs Associate Parexel International, Bengaluru, Karnataka

Regulatory Affairs Associate Parexel International, Bengaluru, Karnataka

anilkumar

Mr. Anilkumar Walikhindi

General Manager for Regulatory Affairs at Micro Labs Ltd, Bengaluru.

General Manager for Regulatory Affairs at Micro Labs Ltd, Bengaluru.

nethravathi

Dr. Nethravathi P

Regulatory Professional -I RA CMC and Device

Regulatory Professional -I RA CMC and Device

arun-srikanth

Mr. Arun B Srikanth

Manager, Regulatory Affairs Steriscience specialties private limited

Manager, Regulatory Affairs Steriscience specialties private limited

bhaskar-shetty

Mr. Bhaskar Shetty

QA auditor in IQVIA CAPA centre of excellence

QA auditor in IQVIA CAPA centre of excellence

hiriyanna-ganesh

Dr. Hiriyanna Ganesh Bhat

Professor, Department of Quality Assurance, ABMRCP

Professor, Department of Quality Assurance, ABMRCP

Committee Members

  • Dr. Manjunatha PM, Principal, ABMRCP
  • Dr. Shivanand K Mutta, Professor, ABMRCP
  • Dr. Sateesha SB, Professor, ABMRCP
  • Dr. Gurubasavaraja Swamy PM Professor, ABMRCP
  • Dr. Venkatesh DP, Professor, ABMRCP
  • Dr. Suresh Janadri, Associate Professor
  • Mr. Russel Martin, Assistant Professor, ABMRCP

Day - 1 : Tuesday - 17th Sept 2024

Time Program Registration
09:30 AM - 10:00 AM Registration Organizing Committee
10:00 AM - 10:10 AM Welcome Address Organizing Committee
10:10 AM - 10:15 AM Inauguration & Lighting of the Lamp Organizing Committee
10:15 AM - 10:20 AM Introduction to the FDP Program Organizing Committee
10:20 AM - 10:30 AM Brief about 5 days Program Schedule Dr. Shivanand K Mutta
10:40 AM - 12:45 PM Hands on Training on pharmaREADY Software Mr. Russell Martin
02:00 PM - 04:00 PM Hands on Training on pharmaREADY Software Dr. Shivanand K Mutta

Day - 2 : Wednesday - 18th Sept 2024

Time Program Resource Person
10:00 AM – 12:45 PM Hands on Training on pharmaREADY Software Dr. Shivanand K Mutta
02:00 PM - 04:00 PM Hands on Training on pharmaREADY Software Mr. Russell Martin

Day - 3 : Thursday - 19th Sept 2024

Time Program Resource Person
10:00 AM - 10:20 AM Welcome Address Organizing Committee
10:20 AM - 10:40 AM Addressing the Gathering by Guest Dr. Sangamesh Purnik,
Founder and Director,
Thiagrow labs private limited.
10:40 AM - 10:45 AM Addressing Gathering by Principal Dr. Manjunatha PM
10:45 AM - 11:00 AM Tea break -
11.00 AM - 01:00 PM Global requirements for registration of biosimilars and eco pharmacovigilance & proud: a programma for removal of unused drugs. Dr. Sangamesh Purnik,
Founder and Director,
Thiagrow labs private
limited.
01:00 PM - 02:00 PM Lunch Break -
02:00 PM - 04:00 PM CEP filing and fundamental difference from USDMF Dr. Hiriyanna Bhat,
Professor,
Department of Quality Assurance, ABMRCP.

Day - 4 : Friday - 20th Sept 2024

Time Program Resource Person
09:30 AM - 10:00 AM Welcome address for Guests Organizing Committee
10:00 AM - 11:00 PM Risk-Based monitoring in clinical trials Mrs. Vanajakshi M
11:00 AM - 11:15 AM Tea break -
11:15 AM - 01:00 PM Regulatory requirements for post-marketing studies - US and EU market Dr. Mahesh bk
01:00 PM - 02:00 PM Lunch Break -
02:00 PM - 04:30 PM Role of Hatch-Waxman Act and Orange Book in Generic Drug Development. Book in Generic Drug Development. Mr. Venugopal Regulatory,
Affairs Associate Parexel,
International, Bengaluru,
Karnataka.

Day - 5 : Saturday - 21th Sept 2024

Time Program Resource Person
09:30 AM - 09:40 AM Welcome to guest -
09:40 AM - 10:30 AM An Overview of Regulatory Submission Management and Best Practices for eCTD Submission Preparation and Validation, with Case Studies Ms. Sindhu Sundar,
Regulatory Senior Specialist at Merck
10:30 AM - 11:30 AM Emerging trends and developments in pharmaceutical regulatory affairs Dr. Nethravathi P,
Regulatory Professional -I RA CMC and Device
11.30 AM - 11:45 AM Tea break -
11.15 AM - 01:00 PM Regulatory Affairs pre-approval and post approval overview Mr. Anilkumar Walikhindi,
General Manager for Regulatory Affairs at Micro Labs Ltd,
Bengaluru.
01:00 PM - 02:00 PM Lunch Break -
02:00 PM - 03:00 PM Basics of ICH GCP and Quality Management System in Clinical Research Mr. Bhaskar Shetty
QA auditor in IQVIA CAPA centre of excellence
03:00 PM - 04:00 PM Global Regulatory Submission Excellence for Parenteral Products: Innovations and Key Strategies Mr. Arun B Srikanth Manager,
Regulatory Affairs Steriscience specialties private limited
04:00 PM - 04:30 PM Evaluation of programme, Valedictory and Feedback Organizing committee
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