• Regulatory
• Regulatory Operations
• Regulatory Information Management

Webinar Overview:
This session focuses on how the Regulatory Operations (RegOps) function is evolving driven by several technology and regulation factors. It will reference several large Regulatory and AI / Automation studies by Gens & Associates coupled with extensive experience working with organizations to answer:

     - What will RegOps look like in 2030 (skills, roles, remit).
     - What is real vs hyped to AI/Automation impact on RegOps.
     - How does the Evolving Regulatory landscape influence business considerations for AI/Automation.

Presenters:

Danielle McVey, Director, Regulatory Innovation & Compliance Excellence


With a strong foundation in people management, Danielle began her career developing and leading teams to their highest potential. Transitioning into the pharmaceutical regulatory field, Danielle started as a Regulatory Submission Specialist, quickly advancing to managerial and leadership roles. Driven by a passion for continuous improvement, Danielle moved into strategic initiatives, focusing on Program & Change Management. Danielle has led numerous change management workstreams, developing strategies to facilitate smooth transitions and foster a culture of adaptability.

Throughout Danielle’s career, she has demonstrated a commitment to excellence, a keen aptitude for learning, and a dedication to achieving improved results. Danielle’s journey blends people management expertise and strategic leadership in the pharmaceutical regulatory domain, with a strong focus on change management in Regulatory Innovation.


Preeya Beczek, Managing Director, Beczek.COM

Preeya has 25 years’ experience across the life sciences industry. She has led regulatory projects across the entire product lifecycle in various therapeutic areas and platforms. Preeya has held roles at PAREXEL, GSK, Pfizer, JNJ, Ipsen, DOW Chemicals and worked with many other organisations as part of her client base and professional network. 

Preeya has extensive industry experience and insights to lead and support teams across regulatory and compliance functions, in order to meet objectives, set by senior leadership. 
She has undertaken many large strategic and operational projects to help organisations reach operational effectiveness and increase regulatory compliance. 

Some examples include: labelling alignment between core and local versions, critical phase submission management, inspection preparation and readiness for EMA and MHRA, expansion of product regulatory strategy to include new EU countries in a centralised procedure registration, sustained improvement in lead times by 30% for secondary packaging development; integrating knowledge and resources to allow early product launch ahead of competitor; standardisation of global submission management processes; designing and establishing risk management and governance frameworks; collaborating in a change network to enhance e2e labelling change management processes and system, increasing compliance to 90 % in 6 months, building the full RA and cross functional infrastructure for first MAH product.

Preeya is an excellent facilitator and a ‘critical friend’, working with clients and cross functional teams operationally and as a subject matter expert. She is passionate about creating effective teams, processes, toolkits and operating models for RA teams to enable global collaboration, data quality and compliance. 

Preeya holds a Bachelor of Science degree in Chemistry and Management Studies and a Master of Science in Environmental Strategy from the University of Surrey, UK. She is also a qualified Lean Six Sigma Green Belt.

Pricing

Standard

• Member: Free
• Non-Members: £45.00