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6th Annual Global Pharmaceutical Regulatory Affairs CMC Conference

October 29-30, 2020 | Philadelphia, PA

6th Annual Global Pharmaceutical Regulatory Affairs CMC Conference
October 29-30, 2020 | Philadelphia, PA

Request Invite

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

“I thought the conference was excellent!  Having a conference tailored to one discipline made each panel and contact relevant.”

Director, Compliance & Legal Affairs
Orexigen

“Great insight to hear payer perspective in contracting and account management and the changing healthcare landscape.”

Channel Liaison
Biogen

“It was definitely an excellent well-rounded opportunity to meet new people, get new ideas, and get an in-depth education on what’s to come with the FDA collaborations.”

Quality Engineer
Centurion Medical Products

“It was very well organized event and high quality, the fact to have an IVD track was also interesting. Thanks, I will recommend the Q1 event!”

Regulatory Affairs – EMEA Regional Head
BIOMERIEUX

“The organization and support staff were fantastic! I’m looking forward to next year.”

Global Business Project Lead
Genentech

About the Conference:

Regulatory affairs chemistry, manufacturing and control operations are a critical component for the success development, approval, manufacturing, and marketing of consistently highly effective and safe therapies. As products continually become more complex in not only product design but in the compound and chemical makeup, CMC executives are challenged with obtaining the high levels of evidentiary support to showcase the product’s overall performance and quality. Building on conference knowledge share and success of this annual conference, the 2018 program will showcase industry experts within CMC operations, who as presenters will share experiences and knowledge that will be of great benefit to all attending delegates.

Core Topics to be Addressed:

  • Impact of ICH Q12 changes in current post approval change processes
  • Strategies for successfully navigating KASA submission operations
  • Expedited pathways: CMC operational strategies for condensed timelines
  • Stability expectations in early stage therapeutic product development
  • Navigating the complexities of CMC processes for combination products

Program Highlights:

  • Interactive discussions supporting collaborative group sharing
  • Highlighting both US and global regulatory expectations
  • Multiple stakeholder presentations from industry and legal experts

Core Topics to be Addressed:

  • Impact of ICH Q12 changes in current post approval change processes
  • Strategies for successfully navigating KASA submission operations
  • Expedited pathways: CMC operational strategies for condensed timelines
  • Stability expectations in early stage therapeutic product development
  • Navigating the complexities of CMC processes for combination products

Request Invite

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 progress

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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