RIC Leadership

Kevin Holman, MBA, RAC, RIC Board Member & Chairperson
Johnson & Johnson Innovative Medicine

Kevin Holman, MBA, RAC leads the REMS & Risk Management Center of Excellence at Johnson & Johnson Innovative Medicine where he built and leads a team of risk management experts to oversee the design, implementation, management, and assessment of risk management programs in the U.S. and North America. Throughout his career, Kevin has contributed to nearly half of the currently-approved shared REMS programs and dozens of single-product REMS programs across various therapeutic areas. Kevin holds a Master of Business Administration degree from Webster University, a Bachelor of Science degree in Biological Sciences from Southern Illinois University ‒ Edwardsville, and a Regulatory Affairs Certification (US-RAC) from the Regulatory Affairs Professional Society.

Kishore Gopu, MS, MBA, RIC Board Member & Vice Chairperson
Teva Pharmaceuticals

Kishore Gopu, M.S., MBA, Senior Director, REMS Operations has been with Teva since 2007 and has served in many departments including Regulatory Affairs, Commercial Operations, Patient Solutions, Market Access, and Pharmacovigilance. Since joining Teva, Kishore has built the REMS department from the ground up and has been leading it for the last nine years. Prior to Teva, he worked/consulted for many large corporations, including Wyeth and Johnson & Johnson, for six years. He was involved in the development and implementation of over a half dozen shared REMS programs including the iPLEDGE®, TIRF REMS, Opioid REMS, and Clozapine REMS to name a few, and continues to be responsible for the oversight of Teva’s REMS portfolio. Kishore holds a M.S. from the University of South Carolina and a MBA from Fairleigh Dickinson University.

Kal Elhoregy, RPh, PA, RIC Board Member & Treasurer
Marketing & Communications Working Group Co-Lead
Amneal Pharmaceuticals

Kal Elhoregy is an accomplished healthcare industry executive with 25+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems and Pharmacovigilance Quality and Compliance for companies within the pharmaceutical industry. In his current role as a Senior Director, Risk Management and Pharmacovigilance Compliance - Global Patient Safety at Amneal Pharmaceuticals, he manages all Global Risk Management activities including Risk Evaluation and Mitigation Strategies (REMS), Risk Management Plans (RMP) and the Pharmacovigilance Compliance unit and ensures the entity’s full compliance with the regulatory requirements of Pharmacovigilance and Risk Management. 

As a strategist and accessible leader with experience in Pharmacovigilance and Quality Risk Management within the pharmaceutical industry, Kal has developed the infrastructure for managing all REMS programs and RMPs in collaboration with multiple disciplines. He is known for his strong project management strategic skills, increasing organizational capacity through streamlining complex processes, and helping multiple disciplines to effectively manage compliance risk in accordance with regulatory guidelines with the main goals of ensuring patient safety and regulatory compliance. He is a registered and licensed Pharmacist and holds a Bachelor of Science, Accounting from the Faculty of Commerce, Ain Shams University and Bachelor of Science of Pharmacy from Arnold & Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, NY. His experience within the Health Care settings including Pediatric Intensive Care Units and Critical Care Unit Pharmacies, with main responsibilities as a lead infusion Pharmacist. Also, his experience within the pharmaceutical industry includes a strong expertise and leadership in Pharmacovigilance Compliance, Quality Risk Management and Quality System of PV, REMS, Risk Management Plan (RMP), Project Management, GVP / CSV Risk Based Audit, Validation strategies in PV, Good Clinical Practice QA, Vendor Management, and Inspection Readiness.

Kal believes in leadership and teamwork and focuses on what is important to achieve successful results in ensuring patient safety and regulatory compliance. 

Michael Cheung, DHSc, MS, RIC Board Member & Secretary
Bristol-Myers Squibb

Michael Cheung, DHSc, MS is the Executive Director of Global Risk Management, REMS and Risk Management Strategy at Bristol Myers Squibb where he leads a team focused on establishing and supporting the company's U.S. REMS programs and global risk management strategies to support their expanding and evolving portfolio. With over 20 years of biopharmaceutical industry experience spanning pharmacovigilance, medical affairs, clinical research, and risk management roles, Michael leans on his broad experience to ensure patient safety. Michael holds a Doctor of Health Sciences degree from A.T. Still University, a Master's degree in Regulatory Affairs from Northeastern University, and a Bachelor's degree in Kinesiology from San Diego State University.

Ron Selders, RIC Board Member
Viatris

Ron Selders, R.Ph., Pharm.D., MBA, Senior Director has been with Viatris (formerly Mylan) for over 25 years and is currently leading the Product Safety and Risk Management department for the Americas region.  Throughout his career, Ron has developed expertise covering a wide-ranging product portfolio in areas such as pharmacovigilance operations, safety surveillance, governance/compliance, audits, and inspections. He also has experience with pharmacovigilance related company and product integration activities. Ron holds a Bachelor of Science degree in Pharmacy and a Masters in Business Administration degree from West Virginia University as well as a Doctor of Pharmacy degree from the University of Colorado.

Cherie Johnson, RIC Board Member
Jazz Pharmaceuticals

Cherie Johnson, is the Sr Director, REMS Strategy & Operations at Jazz Pharmaceuticals.  Cherie has over 25 years in the industry at Jazz Pharmaceuticals and Orphan Medical with a specific focus on risk management programs and REMS oxybate products with Jazz Pharmaceuticals and Orphan Medical.  At Orphan Medical, Cherie helped develop, implement and manage a risk management program required for oxybate in the U.S., and led the development of the Patient Services department.  Cherie continued her career and role with Jazz Pharmaceuticals leading Patient Services and managing day to day operations with the oxybate risk management program for over 10 years and then transitioned to a role in REMS with specific responsibilities that include the ongoing REMS development, implementation, operations, compliance, and oversight of Jazz REMS programs.

Tina Latch, RIC Board Member
Endo

Tina Latch, has an extensive background in pharmacovigilance and risk management, has been a pivotal figure at Endo since 2009. As the Senior Director, she oversees the company's U.S. REMS programs for both branded and generic products. She has 25+ years of experience in the biopharmaceutical industry encompasses a broad range of expertise, including medical affairs, clinical research, pharmacovigilance, and risk management. Prior to Endo, Tina was at Johnson & Johnson, for ten years in Clinical Data Management, bringing new therapeutic products to market. She has been involved in the development and implementation of numerous shared Risk Evaluation and Mitigation Strategy programs. These programs include those for Alosetron, Alvimopan, Ambrisentan, Mycophenolate, Opioids, Vigabatrin as well as others. Her leadership continues to guide the strategic direction of Endo's REMS portfolio, ensuring patient safety and regulatory compliance. Tina holds a Bachelor of Science in Nursing degree from the University of Delaware

Jamie Wilkins, PharmD, RIC Board Member
Pfizer, Inc.

Jamie Wilkins, PharmD, is a leading expert in pharmacovigilance, risk management and global safety policy, with a robust background as a regulator at the US FDA and in the pharmaceutical industry. Dr. Wilkins holds a Doctor of Pharmacy degree from the University of Maryland School of Pharmacy and has dedicated her career to advancing drug safety through innovative pharmacovigilance and risk management strategies. Currently, Dr. Wilkins serves as the Head of the Risk Management Center of Excellence and Pharmacovigilance Policy Committee at Pfizer, Inc. where she is instrumental in shaping global safety policies and overseeing global risk management strategy and operations. In addition to her expertise in pharmacovigilance, Dr. Wilkins is passionately involved in educational initiatives aimed at enhancing pharmaceutical practices in low- and middle-income countries (LMICs). She manages global medical grant programs designed to build local capacity, improve drug safety practices, and foster knowledge sharing in these regions. Dr. Wilkins is an active contributor and steering committee member to the BeCOME initiative, where she works to influence global safety standards and advocate for evolution of pharmacovigilance and pharmacoepidemiology solutions worldwide. In addition, she sits on the board of directors for the REMS Industry Consortium (RIC). Her dedication to improving global health through education and policy has established her as a respected leader in the field.

Carmit Strauss, PharmD, RIC Board Member
Takeda

Carmit Strauss PharmD, is an Executive Director at Takeda overseeing the risk management, Organ toxicity and Benefit Risk centers of excellence. She has an extensive experience in risk management working in various leadership roles within Safety and Pharmacovigilance and Medical Affairs.  

Carmit has a broad range of experience in risk management and benefit risk assessment planning, risk minimization and REMS design, implementation and evaluation. Her expertise also includes risk communication and patient-centered approaches and methodologies. In her current role Carmit provides leadership and subject matter expertise in Risk Management, Benefit/Risk assessment and Organ Toxicity and ensures identification and mitigation processes are continuously improved to reflect regulatory trends/guidelines and best practices. 

Carmit has been actively collaborating with various cross-industry groups and projects and is a member of CIOMS XII working group on Benefit-Risk Balance for Medicinal Products. Carmit has authored multiple scientific and benefit risk and risk management abstracts and publications as well as presented at different benefit risk related conferences on various topics.

Carmit obtained her PharmD at the University of Southern California (USC) and holds a Bachelor of Science degree in Microbiology Immunology and Molecular Genetics from University of California Los Angeles (UCLA).  Carmit completed her industry post-Doctoral fellowship at Baxter Bioscience.