17
May

08:00 AM EDT

Regulatory Affairs
Strategy Meeting East Coast USA 2023

The premier meeting for all East Coast USA Regulatory Affairs professionals

Le Meridien Cambridge Boston

A MEETING EXPERIENCE UNLIKE ANY OTHER

Fresh Regulatory Affairs Insights

Tired of the same conference experience? Real discussions and genuine networking are often promised, but not always delivered. Proventa International’s Manufacturing Strategy Meetings are designed to avoid the pitfalls of a typical conference, by providing the right environment to make those important connections through interactive roundtable discussions, exclusive networking and keynote panel debates. Join Regulatory Affairs professionals from across the East Coast, in Boston MA, to discover new insights and take your company’s mission to the next level.

What makes our strategy meetings unique?

Roundtable Discussions

Intimate discussions led by renowned industry experts. Have your voice heard and debate alongside like-minded life science executives.

Unrivalled Networking

With senior delegation from big pharma and innovative biotech from across the East Coast, you can network with peers from different locations, all in one place.

Personalised Agenda

Choose the topics that matter to you. Reserve your place at the roundtable discussions and ensure your whole day delivers the insights you need to hear.

Solutions to your Problems

We’ve partnered with the best solution providers to solve your biggest challenges. Engage in pre-arranged, private meetings to address your specific needs and find a tangible solution.

Industry Researched Topics

We guarantee our agenda is up-to-date and mission critical because its designed by you. We speak to our extended network of senior decision makers to ensure the most important topics are discussed.

Senior Decision Makers

The entire strategy meeting is specifically tailored to the needs and challenges of senior life science professionals. Discover how your peers are dealing with the same challenges as you.

Meet Our Facilitator

Our panel of facilitators play a key role in shaping the agenda for the day. Whilst we?re busy connecting with the best industry experts, take a look at 2023’s facilitators

Chitkala Kalidas

Vice President, Global Head Oncology & IVD Regulatory Affairs and Oncology Sustainability Bayer

Gopi Vudathala

Global Head, Regulatory Affairs CMC Incyte

Jamie Gillette

Vice President, Head of Regulatory Cullinan Oncology

Kristen Manion

Vice President, Regulatory Affairs and Quality Paratek Pharmaceuticals

Lauren DiPetrillo

Executive Director, Head of Regulatory Affairs Keros Therapeutics

Margaret Woo

Vice President, Head of Regulatory Affairs and Quality Scorpion Therapeutics

Nanita Cranford

Executive Director, Head of Global Regulatory Operations Regeneron Pharmaceuticals, Inc.

Patrick Guinn

Executive Director and Head, Regulatory Affairs & CMC-RA Mitsubishi Tanabe Pharma Development America

Stan Russell

Vice President, Site Head of Quality Sebela Pharmaceuticals

See the agenda and facilitator line-up. Download the strategy meeting brochure for full details.

DOWNLOAD THE BROCHURE

Reasons To Attend Our Strategy Meetings

Fully Interactive Format

There’s only so much you can learn from presentations and lectures. Instead our interactive Roundtable Discussions let you debate the topics that really matter

Senior Decision Makers

All our Strategy Meetings are aimed at director level and above. Discover how your peers are tackling the industries biggest challenges and have your thoughts heard

Personalised Agendas

Pick the roundtable discussions that you want to be part of. Simply choose your sessions and we’ll create a personalised agenda just for you

Private and Intimate Networking

Small group discussions, private meetings, networking drinks – however you choose to make those important connections our Strategy Meetings have the solution

Our Agenda

See Which Topics Are Discussed at the Strategy Meeting

09:00

Roundtable Tracks

RIM and Data Management Streamlining Global Regulatory Compliance and Information Management Regulatory Operations & Regulatory Strategy Navigating the Regulations and Governance of Gene Editing Technologies Labelling, Artwork, and Regulatory Content Management Utilizing Dynamic Labeling Management Technologies for Effective Content Management, Workflow, and Structured Authoring Regulatory Submissions/eCTD Collaboration with Regulatory Authorities and Agencies: How to Secure Early Engagement and Dialogue? IDMP / DADI What Does the Future Hold for IDMP? Preparations and Implementation Across the World Investment, Private Equity & Venture Capital Partnerships How to Overcome the Common Pitfalls Around Operational Complexities in Mergers and Acquisitions with Ownership Transfer of Such Highly Regulated Drugs?

13:40

Roundtable Tracks

RIM and Data Management How Can Global Pharmaceuticals Stay Ahead of Changing Data Privacy Regulations? Regulatory Operations & Regulatory Strategy Exploring Strategies to Revamp Your Regulatory Infrastructure for Faster, Better, and Stronger Processes Labelling, Artwork, and Regulatory Content Management Understanding the Need for End-to-End Visibility to Labeling Changes Regulatory Submissions/eCTD eCTD 4.0: Definition, Key Changes, and Effect on Submission Content Preparation IDMP / DADI Evaluating the Digital Application Dataset Integration (DADI) Project to Replace Electronic Application Forms Investment, Private Equity & Venture Capital Partnerships Best Practices and Success Factors to Raising Funds and Building an Innovative Biotech Company. Which Assets and Technologies Investors will be Looking for in Your Intellectual Property Portfolio?

15:50

Roundtable Tracks

RIM and Data Management What Are the Distinctions and Similarities Between Data Governance and Data Management, and How Do They Interact? Regulatory Operations & Regulatory Strategy Learning Experiences in Addressing COVID-19 Challenges: The Regulatory Flexibilities and Guidances Labelling, Artwork, and Regulatory Content Management The Future of Structured Content Authoring: Why Are We in Need of It? Regulatory Submissions/eCTD Looking Into the Pivotal Role of AI to Improve the Efficiency of Reviewing Regulatory Submissions IDMP / DADI The DADI Roadmap, Timelines, and How IDMP Preparations Will Be Affected Investment, Private Equity & Venture Capital Partnerships Why CRO M&A Deals Are on the Rise? How Expanding Full Service Capabilities, Through a Strategic M&A Process Brings Global Efficiencies to Sponsors?

Become an official strategy meeting partner. Whatever your business needs, we can help. Get in touch for partnering opportunities

I’D LIKE TO PARTNER

Press play to hear what your colleagues had to say…

Quick Links

Want to find out more?

Find out more details about our Strategy Meetings and other news and events.

Here To Help

Want to know more? Interested in sponsoring the event? Need help registering your team?rnrnJust get in touch and a member of the team will be happy to help.

Europe

USA East

USA West

Webinars

Dinners & Spotlights

R&D

Manufacturing Boston

Chemistry Manufacturing and Controls Strategy Meeting 2023

Regulatory Affairs Strategy Meeting East Coast USA 2023

<img decoding="async" src="https://proventainternational.com/wp-content/uploads/2020/12/location.png" >Le Meridien Cambridge Boston

Fresh Regulatory Affairs Insights

What makes our strategy meetings unique?

Roundtable Discussions

Unrivalled Networking

Personalised Agenda

Solutions to your Problems

Industry Researched Topics

Senior Decision Makers

Meet Our Facilitator

Chitkala Kalidas

Gopi Vudathala

Jamie Gillette

Kristen Manion

Lauren DiPetrillo

Margaret Woo

Nanita Cranford

Patrick Guinn

Stan Russell

Reasons To Attend Our Strategy Meetings

Fully Interactive Format

Senior Decision Makers

Personalised Agendas

Private and Intimate Networking

See Which Topics Are Discussed at the Strategy Meeting

Opening Keynote

Roundtable

Roundtable Tracks

Networking/1-1 Meetings

Roundtable

Networking Lunch

Roundtable

Roundtable Tracks

Networking/1-1 Meetings

Keynote Presentations

Roundtable

Roundtable Tracks

Networking/1-1 Meetings

Drinks Reception

Our Thought Leaders

Press play to hear what your colleagues had to say…

Want to find out more?

Here To Help

Select days you wish to attend You can add multiple days

Pass includes:

VAT Excluded

Select days you wish to attend You can add multiple days

Pass includes:

VAT Excluded

About You

Your Address

About Your Company

This is required field*

Bone/Osteoporosis

Immunology

Orthopaedics

Cardiovascular

Infectious diseases

Pulmonology

CNS

Inflammation

Psychiatry

Dermatology

Internal diseases

Respiratory

Diabetes

Metabolic diseases

Rheumatology

Endocrinology

Nephrology

Surgery

Regulatory Affairs
Strategy Meeting East Coast USA 2023

Le Meridien Cambridge Boston