Webinar on Pharma Regulatory Affairs- 2022
23rd June 2022 / Time:- 11:00 - 13:00
About Us
WEECE Events is inviting to all the pharmaceutical professionals to the Webinar on Pharma Regulatory Affairs- 2022 with the Theme: “Current Regulatory Compliance Issues & Opportunities for Regulatory Authorities and Industry Experts which is going to be held on 23rd June from 11.00 AM onwards.
Regulatory affairs professionals play critical roles in the pharmaceutical industry because they are concerned about the healthcare product lifecycle. It provides strategic, tactical and operational direction and support for working within regulations to promote the development and delivery of safe and effective healthcare products around the world.
Pharmaceutical Regulatory Affairs professionals are responsible for developing, compiling, and filing documentation required to support the licensing and approval of pharmaceutical drugs. This is reflecting that dialogue between regulators, industry and scientist has become more and more important because Regulatory Affairs is a highly regarded profession within pharmaceutical companies.
In this Webinar, we are covering the current regulatory compliance issues & opportunities for regulatory authorities and industry experts.
How will you be benefited from this webinar?
Understand the background legal framework for pharmaceuticals- regulations, directives and guidelines
- Advanced your knowledge of current events in regulations
- Upgrade Professionals Skills
- Get prepared for future challenges in Pharmaceutical Industry
- Prepare to manage a variety of challenging regulatory issues in the markets
23 June
Delhi - India
150+ Tickets
04-Speakers
SPEAKERS
Dr. Sarika Pardhe
Founder & Principal Consultant,
AblyReg Advisory
Dr. Rajni Jha
Pharmaceutical Consultant & Trainer,
Ex Head Of GMP and Regulatory Affairs- Naari Pharma
Ms. Adity Sen Pal
Associate Vice President,
Indoco Remedies Ltd.
MODERATOR
Dr. Prafulla Nandi,
Pharmaceutical Regulatory Expert, Former Senior Vice President
Global Regulatory Affairs, Laurus Labs Limited, Hyderabad.
Event Schedule
11:00 -11:10
11:10- 11:25
11:25 - 11:55
11:55 - 12:25
12:25 -12:55
12:55 - 1:00
Media Partners
Event Topic
TOPIC 1: Regulatory Strategies, Development and Emerging Markets in Pharmaceutical Industry.
A regulatory strategy can be defined as a science-driven assessment of a product’s development options, key consider- actions and likely regulatory outcome. It should span the earliest development stages through further modifications planned post authorization.
The ultimate goal of a regulatory strategy is to enable patient access, and it is within this context that a regulatory professional must provide a regulatory strategy. A regulatory strategy can be defined as a science-driven assessment of a product’s development options, key considerations and likely regulatory outcome. In the current environment, regulatory intelligence is generally the monitoring, gathering, and analysing of publicly available and experience-based regulatory information needed to develop a strategy for time- and cost-saving drug development. Regulatory intelligence is not just information and knowledge management.
TOPIC 2: The Risk Challenges and Future Development in Regulatory Affairs in India Market.
Currently, global regulatory submissions (dossiers) and strategic development plans must be tailored to accommodate a range of specific local requirements for data and regulatory obligations in their target markets. The R&D woes of the pharmaceutical industry are well known4 and include increased costs, fewer innovations and a looming patent cliff. Industry’s task is made more difficult by the global variations in existing regulations. Regulators are reconsidering their roles as guardians of drug safety, quality and efficacy and supporters of the drug supply. Adequate drug supply is dependent upon the viability of the healthcare industry, which, in turn, will be helped by sustained global initiatives to harmonize regulations for medicinal products, thereby reducing the burden of costly local regulations and data requirements.
TOPIC 3: How , What and Why Regulatory Affairs in Pharma Industries .
The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.
A career in Regulatory affairs is one of the versatile professions one can ever come across because it provides diversified employment opportunities that too at various levels. Even though Regulatory Affairs is one of the most interesting and rewarding careers but still it has its own challenges. The main objective of regulatory affairs is to provide the basis for the assurance of high quality of food products which can increase consumer’s interest for ensuring the efficacy, quality, and safety.