Date(s) And Time(s):
Apr 13 2012 8:30AM - Apr 14 2012 5:00PM
Location:
ITC Maratha
Sahar
Andheri (E)
Mumbai 400099
Maharashtra
India
http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr...
Pharmaceutical manufacturers in India are facing many challenges within the domestic and global regulatory environment. These challenges include manufacturing and quality control, testing and packaging. This conference will provide interactive sessions on many of these issues including discussion on strategies to achieve global regulatory compliance.
FEATURED TOPICS
• Focus on Recent Changes in EU, US and Emerging Market’s Regulatory Landscape
• Complex Generics—Regulator’s Role in Driving the Agenda
• Evolving Biosimilar Regulation in India and Overseas
• Drug Regulatory Affairs—Profession and Career
• Quality Assurance and Compliance
• Quality by Design—Guiding Principles in Drug Development Leading to Robust Regulatory Submission
• Regulatory Operations—CTD and Beyond
• Pharmacovigilance
--------------------------------------------------------------------------------
All attendees will receive a DIA Certificate of Attendance at the conclusion of the event
--------------------------------------------------------------------------------
Learning Objectives:
LEARNING OBJECTIVES
This conference will bring together regulatory professionals, academia and regulators to discuss various aspects of evolving global regulatory landscape particularly around:
• New changes in EU regulatory environment e.g. new variation guideline and implementation, pediatric regulation
• Emerging and evolving biosimilar regulation in India, EU, US, S. Korea, Brazil and Russia
• Focus around Complex Generics and evolving understanding
• Quality and compliance in manufacturing and clinical trials
• Special focus on regulatory affairs’ profession and career with Q&A with leading regulatory professionals
Event Code:
12651
Contact Information:
MEETING CONTACTS
MEETING MANAGER: Manoj Trivedi, Senior Manager Marketing and Program Development, DIA (India) Private Limited Cell: +91.98.1977.7493, Tel: +91.22.6765.3226 email: Manoj.Trivedi@diaindia.org