Uncover insights and best practices in electronic submission processes to accelerate time-to-market
Managing regulatory submissions is a challenge for many pharmaceutical companies as they wrestle with the vast amount of information exchanged within their own department, affiliates and regulatory authorities. The process is often manual, labor-intensive, error-prone and inefficient – all of which can lead to delayed time to market, lost revenue and failed filing processes.
Despite having purchased solutions to help with the submissions process, the last leg remains a highly-manual process. Current systems do not address the electronic submission process to the health authorities, leaving these companies still stuck managing volumes of data manually.
Developing drugs amidst challenging market conditions over an 8-10 year development cycle is just part of the job. Regulatory departments must then work to get their products approved by the respective governing bodies which is ever-evolving in standards (i.e. eCTD, xEVMPD, ISO IDMP) and varies by filing jurisdiction.
Regulatory departments often struggle with transmitting information in the required format while maintaining an audit trail throughout the process. To solve the problem many look to a mix of home-grown solutions, physical media and purpose-built applications which fall short in managing the end-to-end workflow.
Join this webinar where you can learn how to overcome challenges in the submission process which can help accelerate the drug approval process, getting products to market faster and generating a positive ROI sooner.
Register today to uncover insights and best practices in electronic submission processes! Further, for a limited time we're offering all webcast attendees a complimentary consultation that can help you uncover where you are today, where you want to be and what steps you can take to get there.
Presented by
Wim Cypers,
SVP Regulatory and Safety – ArisGlobal
Wim is responsible for the research, development and deployment of all regulatory products offered by ArisGlobal including managing the impact of ever-changing regulatory shifts into all the products in the ArisGlobal portfolio. He is also a frequent speaker and presence at numerous IDMP, regulatory affairs and safety/PV events around the globe.
In his 18 years with ArisGlobal, Wim has held various senior product and business development positions supporting ArisGlobal domains. Before joining ArisGlobal, Wim was a project leader at Janssen Pharmaceutica, a research pharmaceutical division of Johnson & Johnson, Inc., based in his home country – Belgium. He is an industrial pharmacist trained at the Katholieke Universiteit Leuven, a major European center for higher learning.
Lakshmeenarayana Goundalkar (LGG),
Global Director – Professional Services (Regulatory Affairs) – ArisGlobal
“LGG†is responsible for professional services and support for regulatory solution suite globally as part of ArisGlobal organization. He has worked with major pharmaceutical and medical device companies to deliver solutions addressing key business requirements from regulatory affairs and operations.
Now in his 15th year at the company, he has contributed in various roles in the organization in terms of architecture, design, development, implementation and support suite of products for regulatory affairs. He is pursuing Masters in Regulatory Affairs from North-Eastern University and Bachelor in Electrical and Electronics Engineering degree from Bangalore University.
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