The expedited schemes available from global regulatory bodies offer significant advantages for drug product developers. While the basic tenants of quality, safety and efficacy testing remain, such programs have been introduced to rapidly get cutting edge treatments to target patient populations.
The ability to design expedited assessment programs, get drug reviews done quickly with low- and no-cost input from regulatory bodies helps expedite treatments for serious conditions and unmet medical needs.
An increasing array of such schemes now exist in Europe, America, Japan and Australia, with many other countries adapting and adopting them for their own use. This webinar will summarize currently available and supporting expedited programs around the world, and present design considerations to unlock their potential to minimize the time to market, and maximize the reach of your therapeutic to target patient populations.
Speaker
Sanjay Jain, PhD, MTOPRA, Principal Consultant, Pharma Consulting, Envigo
Sanjay Jain is a pharmaceutical professional with over 20 years of diverse, extensive and multicultural drug and product development experience in biopharmaceutical, pharmaceutical, CRO and academic environments. He has worked with a wide spectrum of products including biologics, drug delivery systems (DDS) and new chemical entities (NCEs). He is a pharmacist with a PhD in Pharmaceutical Sciences and a post-graduate diploma in management of pharmaceuticals. Sanjay joined Envigo in 2014 as the Principal Consultant of Pharmaceutical Consulting in Regulatory Affairs.
Who Should Attend?
This webinar will appeal to individuals working in drug development, translational medicine and regulatory affairs with the following or related jobs titles:
- Drug developers
- Chief Scientific Officers
- Associate Scientist
- Principal Scientist
- Senior Scientist
- Director of R&D
- Director of Clinical Operations / Clinical Outsourcing
What You Will Learn?
Attendees will learn about:
- An overview of the current and new expedited schemes
- Key considerations for application and study design
- Do’s and don’ts when approaching regulators
- Practical tips for minimizing time-to-market in target therapy areas
Xtalks Partner
Envigo
Envigo provides mission-critical products and research services for pharmaceutical, crop protection, and chemical companies as well as universities, governments, and other research organizations. Our company is founded on the principle that research partnerships depend on unmatched expertise, unwavering dedication to customer service and shared goals, Envigo is committed to helping customers realize the full potential of their products and research which contribute to enhancing the lives of people and animals as well as protecting the environment.
With over 3,300+ employees serving over 65 countries with a network of more than 25 operating facilities worldwide, Envigo provides comprehensive scientific expertise and a full-service offering in non-clinical research and development, research models and services, regulatory consulting, and analytical support to our customers. Envigo is a privately held global company with corporate headquarters in New Jersey.