Regulatory reliance and desk-top inspections – The new normal?

Affordable Networking & Training
06/24/2020
Online

Will your next regulatory inspection be a desk-top one? Hear from former FDA and MHRA staff how Drug Regulators are doing this and how you need to be ready for your next inspection.

Date: 24th June 2020 Time: 03:00 – 04:00 PM

Synopsis:

Former FDA and MHRA regulators will discuss how regulators are needing to employ desk-top inspection programs during the pandemic and also for the foreseeable future. They will also explain how Regulators are utilizing greater reliance on the work of other Regulators, and will also present on some key considerations to take to prepare your company for a desk-top inspection.

What do participants get from attending?

  • Greater understanding of how Regulators are using desk-top inspections to make regulatory decisions
  • Learn practical steps to take to help prepare your company for a desk-top inspection
  • Understand how Regulators are sharing their inspections findings with each other
  • Gain an insight into how Regulators will restart their on-site inspection programs in the future

Speakers:

Phil Crooker
B.S. (Chem),  J.D.
Vice President – Technical, Regulatory & Access

EXPERIENCE
Two decades of increasingly responsible private sector roles involved with product quality (CMC), regulatory strategy, product development and supply chain operations. Multiple therapeutic areas – including rare disease – in large-cap multinational, start-up and post-IPO, and mid-cap multinational specialty pharmaceutical and biotechnology companies. Regulatory counsel and acting team lead at FDA for compliance and enforcement. FDA policy development for case assessment, records in lieu of inspection, delay/deny/limit/refuse inspections, mutual recognition and cooperative agreements, global task force on nitrosamine impurities, data integrity, guidance and regulations development, and regulatory meetings.

EXPERTISE
Pre-approval product development, regulatory strategy, agency meetings

and submissions for all phases of IND, 505(b)(1) & 505(b)(2) NDA, ANDA, supplements & DMF – small molecules, OTC medications, drug-device and fixed-dose combinations, sterile products and potent compounds. Public health emergency procedures, medical countermeasures, and expedited programs – CTAP, EUA, CGMP waivers, Fast Track Designation, BTD and PRIME, exclusivity analysis and voucher programs. Product lifecycle management, technology transfer and supply chain operations. Manufacturing compliance and enforcement – conventional manufacturing and pharmacy compounding. Due diligence for a variety of parties engaged in life sciences and manufacturing transactions. Applying FDA laws, policies & procedures to anticipate and solve issues affecting regulated industry.

EXPERTISE
Juris Doctor (J.D.), Purdue Global University and Admitted to the California Bar and federal court. Post-graduate education in pharmaceutical sciences at Medical College of Virginia. Bachelor of Science (Chemistry) from Virginia Commonwealth University.


Mark Birse
M.Sc. – Vice President Technical, Parexel
Regulatory & Access

Mark Birse is a Vice President Technical in Parexel’s Regulatory & Access Consulting group. He is a strategically orientated regulatory compliance professional, with a career spanning the regulation of pharmaceuticals and medical devices. Mark has a passion for ensuring patient safety through delivering pragmatic, risk proportionate and innovative approaches to regulation, with a demonstrated success in building and leading high performing teams responsible for multimillion-pound income

Prior to joining Parexel, Mark previously worked at the MHRA where he held several leadership roles, including Deputy Director Inspection, Enforcement & Standards Division and Head of MHRA Inspectorate and Process Licensing Group, a team with over 75 GXP inspectors.

In these roles, Mark worked extensively with international regulators including FDA, EMA and TGA developing compliance and risk-based inspection methodologies with a focus on inspection collaboration and reliance. He was an Executive Bureau member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and also assessed the capability and performance of regulators and provided international training for both regulators and industry. Mark also held leadership roles in the MHRA Medical Device Division with responsibilities for Devices Safety and Surveillance & Software and Apps.

Mark’s background is in GMP having initially joined the MHRA in 2002 as a GMP Inspector where he performed inspections globally. Prior to joining MHRA he spent 10 years in Industry with responsibilities for technology transfer and supplier auditing. He is also eligible as a Qualified Person (QP).


Moderator:

Viswanandh Kuppa

Viswanadh works closely with biopharmaceutical companies for new business acquisition and positioning Parexel as a key strategic partner for Clinical, Commercial and Compliance segments. He brings on board close to two decades of global experience in corporate development, sales & marketing, new business development and portfolio management across products and services. He holds a Senior Management Program from the Indian Institute of Management, Kolkata and a Master’s in Veterinary Medicine with a specialization in Cardiovascular Physiology.

Please note : If you can’t make it on the 24th June 2020, don’t worry!
Register now and you’ll have access to the webinar on demand for 90 days after the live date.

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