5th Annual Global Pharmaceutical Regulatory Affairs CMC Conference

October 29-30, 2019 | Philadelphia, PA
Sheraton Philadelphia University City Hotel

5th Annual Global Pharmaceutical Regulatory Affairs CMC Conference
October 29-30, 2019 | Philadelphia, PA
Sheraton Philadelphia University City Hotel

Download Agenda

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.

Core Topics to be Addressed:

  • Impact of ICH Q12 on Risk-Based CMC Operations
  • Global CMC Guidance & Expectations Including:
    • China
    • Russia
    • Brazil
    • EU
  • Upscaling CMC Activities to Meet Global Demands
  • Tracking Global Change Control Management
  • Considerations in Drug Substance Starting Materials

Program Highlights:

  • Increased Balance Between Biologics & NCEs
  • Coverage of CMC for Combination Products
  • Health Authority Perspectives & Interpretations

Core Topics to be Addressed:

  • Impact of ICH Q12 on Risk-Based CMC Operations
  • Global CMC Guidance & Expectations Including:
    • China
    • Russia
    • Brazil
    • EU
  • Upscaling CMC Activities to Meet Global Demands
  • Tracking Global Change Control Management
  • Considerations in Drug Substance Starting Materials

Download Agenda

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

Audience

75 Attendees

All attendees come directly from pharmaceutical companies

Distinguished Presenters

18 Speakers

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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