9th Annual Pharmaceutical Regulatory Operations and Submissions Conference

November 10-12, 2020 | Virtual Event

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WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

“Very useful to get your mind off of what only your company is doing and into other people’s experiences. This was my first Reg Ops/Subs conference and I want to attend the next one.”

Regulatory Publishing Specialist
CSL Behring

“I appreciate the intimacy of this conference.”

Senior Global Regulatory Operations Manager
Indivior

“I found the program to be extremely beneficial. Unlike other conferences, both days were filled with several opportunities to have round table discussions led by a facilitator. Having this platform to engage with other participates led to some of the most valuable discussions. I left with several new ideas and questions to ask to teams requesting future projects.”

Head of R&D Resource Capabilities
Boehringer Ingelheim Animal Health

“The peer to peer conversations were great! I liked hearing the different feedback.”

Global Labeling Manager
Intuitive Surgical

“Great insight to other company experiences.”

Labeling Specialist
Edwards Lifesciences

About the Conference:

As pharmaceutical and biotechnology products become exceedingly more complex, the necessary information to procure a positive regulatory review and submission approval has rapidly changed. The continued push for harmonized global regulations and impact of new technological capabilities has confronted regulatory operations executives with a multitude of hurdles to overcome while ensuring timely and compliant dossier submissions. Bringing together regulatory operations and submission executives at this annual program, allows organizations to learn best practices in the compilation, formatting and submission of a variety of approval applications.

Core Topics to be Addressed:

Creation of compliant documents for optimal global submissions re-use
Exploring current status of harmonization efforts for approval dossiers
Impact of AI & technology advancements on regulatory operations role
Continued transition of ad/promo submissions under Module 1 format
Strategies to overcome product submission timeline hurdles

Program Highlights:

Highlight content and formatting submission requirements
Interactive discussions and workshops to promote best practices
Blending of perspectives from multiple application formats

Core Topics to be Addressed:

Creation of compliant documents for optimal global submissions re-use
Exploring current status of harmonization efforts for approval dossiers
Impact of AI & technology advancements on regulatory operations role
Continued transition of ad/promo submissions under Module 1 format
Strategies to overcome product submission timeline hurdles

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WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

Audience

75 Attendees

All attendees come directly from pharmaceutical companies

Distinguished Presenters

Speaker recruitment in process

Networking

Networking time is built into the agenda to allow industry peers to connect and exchange ideas

Open Dialogue and Group Share

Each presentation is followed by 10-15 minutes of open dialogue for questions and exchange of best practices

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