Latest news with #regulatoryaffairs
Yahoo
14 hours ago
- Business
- Yahoo
Dr. Jethro Ekuta Joins BP Logix Life Sciences Strategic Advisory Board
Global regulatory leader brings decades of experience to guide the next generation of medical affairs automation. SAN DIEGO, June 16, 2025--(BUSINESS WIRE)--BP Logix, a leading provider of AI-enabled medical affairs automation technology, is proud to announce the appointment of Dr. Jethro Ekuta to its Life Sciences Strategic Advisory Board. Dr. Ekuta is the Chair of the Board of Directors for the Regulatory Affairs Professionals Society (RAPS) and currently serves as Chief Regulatory & Safety Officer at Ascendis Pharma. With over 30 years of experience in regulatory affairs and pharmacovigilance, Dr. Ekuta brings a deep understanding of global compliance, regulatory strategy and innovation in drug development. He has held senior leadership roles at organizations including Ascendis Pharma, Alexion (AstraZeneca Rare Disease), Horizon Therapeutics (Amgen), Johnson & Johnson, Genzyme (Sanofi), Bristol-Myers Squibb, Pfizer and the U.S. Food and Drug Administration (FDA). "We are honored to welcome Dr. Ekuta to our Life Sciences Strategic Advisory Board," said Girish Pashilkar, CEO of BP Logix. "His regulatory insight and leadership will be instrumental as we continue to expand our footprint in the life sciences sector and support teams navigating increasingly complex review and approval processes." "I've spent my career working to improve regulatory systems and processes within the pharmaceutical and biotech industries," said Dr. Ekuta. "I believe BP Logix is uniquely positioned to help life sciences organizations streamline compliance, reduce risk and move faster without compromising integrity. I'm excited to contribute to the company's mission and support its growth in this critical space." In his advisory role, Dr. Ekuta will provide strategic input across marketing, product, and customer engagement initiatives. His appointment is part of a broader effort by BP Logix to deepen its alignment with industry leaders and further tailor its solutions to the evolving needs of life sciences organizations. About BP Logix BP Logix helps medical affairs and regulatory teams at life sciences organizations streamline complex review and approval workflows. Its flagship solution, PubPro, simplifies the publication process, while the broader Approvia platform supports use cases such as MLR reviews, clearance systems, medical information requests and IIS evaluations. With a focus on configurability, compliance and speed, BP Logix empowers teams to reduce risk, improve collaboration and bring high-quality treatments to market faster. To learn more about BP Logix and its work in life sciences, visit View source version on Contacts Media contact: Catie Leary,
Associated Press
14 hours ago
- Business
- Associated Press
Dr. Jethro Ekuta Joins BP Logix Life Sciences Strategic Advisory Board
SAN DIEGO--(BUSINESS WIRE)--Jun 16, 2025-- BP Logix, a leading provider of AI-enabled medical affairs automation technology, is proud to announce the appointment of Dr. Jethro Ekuta to its Life Sciences Strategic Advisory Board. This press release features multimedia. View the full release here: Dr. Jethro Ekuta, member of the BP Logix Life Sciences Strategic Advisory Board. Dr. Ekuta is the Chair of the Board of Directors for the Regulatory Affairs Professionals Society (RAPS) and currently serves as Chief Regulatory & Safety Officer at Ascendis Pharma. With over 30 years of experience in regulatory affairs and pharmacovigilance, Dr. Ekuta brings a deep understanding of global compliance, regulatory strategy and innovation in drug development. He has held senior leadership roles at organizations including Ascendis Pharma, Alexion (AstraZeneca Rare Disease), Horizon Therapeutics (Amgen), Johnson & Johnson, Genzyme (Sanofi), Bristol-Myers Squibb, Pfizer and the U.S. Food and Drug Administration (FDA). 'We are honored to welcome Dr. Ekuta to our Life Sciences Strategic Advisory Board,' said Girish Pashilkar, CEO of BP Logix. 'His regulatory insight and leadership will be instrumental as we continue to expand our footprint in the life sciences sector and support teams navigating increasingly complex review and approval processes.' 'I've spent my career working to improve regulatory systems and processes within the pharmaceutical and biotech industries,' said Dr. Ekuta. 'I believe BP Logix is uniquely positioned to help life sciences organizations streamline compliance, reduce risk and move faster without compromising integrity. I'm excited to contribute to the company's mission and support its growth in this critical space.' In his advisory role, Dr. Ekuta will provide strategic input across marketing, product, and customer engagement initiatives. His appointment is part of a broader effort by BP Logix to deepen its alignment with industry leaders and further tailor its solutions to the evolving needs of life sciences organizations. About BP Logix BP Logix helps medical affairs and regulatory teams at life sciences organizations streamline complex review and approval workflows. Its flagship solution, PubPro, simplifies the publication process, while the broader Approvia platform supports use cases such as MLR reviews, clearance systems, medical information requests and IIS evaluations. With a focus on configurability, compliance and speed, BP Logix empowers teams to reduce risk, improve collaboration and bring high-quality treatments to market faster. To learn more about BP Logix and its work in life sciences, visit View source version on Media contact: Catie Leary, [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: TECHNOLOGY HEALTH TECHNOLOGY SOFTWARE NETWORKS INTERNET MANAGED CARE HEALTH DATA MANAGEMENT ARTIFICIAL INTELLIGENCE SOURCE: BP Logix Copyright Business Wire 2025. PUB: 06/16/2025 07:00 AM/DISC: 06/16/2025 06:59 AM
Entrepreneur
20-05-2025
- Business
- Entrepreneur
Zepto Appoints Rachit Ranjan as Chief Public Policy Officer Amid Rapid Growth
With over 15 years of experience in public policy, Ranjan brings deep expertise from his leadership roles at Dream11, WhatsApp, JUUL Labs, and Uber. You're reading Entrepreneur India, an international franchise of Entrepreneur Media. Quick commerce platform Zepto has announced the appointment of Rachit Ranjan as its Chief Public Policy Officer. In this newly created role, Ranjan will lead the company's policy, regulatory, and government affairs functions as it expands its operations across India. With over 15 years of experience in public policy, Ranjan brings deep expertise from his leadership roles at Dream11, WhatsApp, JUUL Labs, and Uber. At Uber, he served as Head of Policy for North India and Federal Affairs, where he played a key role in shaping the company's regulatory strategy and stakeholder engagement. "We're thrilled to welcome Rachit to Zepto," said Aadit Palicha, Co-founder and CEO of Zepto. "As we scale rapidly across India, having a sharp, mission-driven leader in public policy is more important than ever. Rachit brings a deep understanding of the policy landscape and a proven ability to build trust with diverse stakeholders—qualities that are crucial to navigating a fast-evolving regulatory environment and building long-term value." Zepto delivers over 25,000 products within 10 minutes through its network of dark stores. Backed by USD 1.85 billion in funding, including a USD 340 million round in August 2024, the company recently completed a reverse merger to shift its headquarters from Singapore to India in preparation for its planned IPO. On his new role, Ranjan said, "Zepto's incredible growth story has captured the imagination of the entire country. I'm thrilled to join Zepto at such a transformative time. I look forward to working with the amazing team to deliver innovation that is responsible and aligned with the broader vision of inclusive growth." Zepto also recently launched 'Zepto Atom', a subscription-based consumer analytics service, marking its foray into data analytics.
Yahoo
19-05-2025
- Business
- Yahoo
EU (European Union)/United Kingdom Proposed Pharmaceutical Legislation Changes Training Course (ONLINE EVENT: May 19, 2025)
Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "EU (European Union) Proposed Pharmaceutical Legislation Changes Training Course" training has been added to offering. The course is designed primarily for regulatory affairs personnel, however, it will also be of value to those who interact with the regulatory affairs function and would benefit from an understanding of action timelines and strategic factors in obtaining and maintaining marketing authorisations. In the dynamic and highly regulated field of pharmaceuticals, staying abreast of regulatory affairs is crucial for ensuring compliance, maintaining market authorisations, and effectively managing drug development and post-approval obligations. Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging. This is where a comprehensive understanding of pharmaceutical regulatory affairs is invaluable. It is important that companies are aware of proposed changes to pharmaceutical legislation in the EU and the potential impact on company planning and strategy. The EU (European Union) on 23rd April 2023 published proposed changes to pharmaceutical legislation. Discussions between the EU Commission, the MS (Member State) and all stakeholders are ongoing. Review by the European Parliament and the EU Council is required before ratification and implementation which is unlikely to be implemented before 2025/2026. Developing products is a lengthy process and the cost of developing new and modified products is increasing. It is therefore important to be aware of procedures and timelines for obtaining marketing authorisations and importantly to know what if any post approval data and marketing protection will be available. The programme will cover current pharmaceuticals legislation in the EU. The background to the proposed changes in pharmaceuticals legislation will be outlined with discussed in the relevant sections including proposed changes to procedures for obtaining marketing authorisation in the EU, and post-authorisation data and marketing protection criteria and periods. The UK is no longer a member of the EU but knowledge of interactions and collaboration with the EU and other regulatory agencies are essential for obtaining and maintaining marketing authorisations in the UK. The format will provide opportunities for discussion and for sharing of concerns and experiences with our expert trainer and other delegates. Benefits of attending Understand the legal basis of the EU regulatory environment Discuss the background to and the proposed changes to EU Pharmaceuticals legislation Review current and proposed procedures for applying for a marketing authorisation in the EU/EEA and in the UK Consider post-authorisation data and marketing protection Learn about proposed changes to the EMA responsibilities and function Certifications: CPD: 3 hours for your records Certificate of completion Who Should Attend: Regulatory affairs Project management Business planning Commercial management Labelling and artwork Medical information Manufacturing and QA Key Topics Covered: Introduction of presenter and participants Aim of course Background Background to proposed EU legislation changes Proposed changes to EU pharmaceuticals legislation Pre-submission Development advice Discussion re adaptive procedures Submission procedures EU procedure for obtaining marketing authorisation and proposed changes The EMA Centralised Procedure (CP) The Co-ordination Group Decentralised Procedure (DCP) Submission procedures (continued) Mutual Recognition Procedure (MRP) National procedures Including UK procedures Post-authorisation Post-authorisation data and marketing protection and proposed changes Post-authorisation obligations and proposed changes Institutional and wider issues Product supply One Health Environmental protection Q&A and discussion Speakers: Norah Lightowler Lightowler Associates Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twentieth year of successful business. Norah has wide experience in the pharmaceutical and related neutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
12-05-2025
- Business
- Associated Press
Pharmaceutical Regulatory Affairs in China - 2 Day Online Training Course (June 25-26, 2025)
DUBLIN--(BUSINESS WIRE)--May 12, 2025-- The 'Pharmaceutical Regulatory Affairs in China Training Course (ONLINE EVENT: June 25-26, 2025)' has been added to offering. Explore the comprehensive landscape of pharmaceutical marketing authorization in China, including Hong Kong, Macau, and Taiwan, through this specialized two-day seminar. This seminar will provide an invaluable overview of how to gain and maintain a successful pharmaceutical marketing authorisation in the People's Republic of China (PRC), including Hong Kong, Macau and Taiwan. The two-day course will cover: Benefits of attending: Who Should Attend: This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and in-market regulatory compliance in this region. You will find this seminar useful both as an introductory or refresher course. Previous delegates have included scientists and technical staff in regulatory affairs and registration departments, medical directors, and personnel from analytical research and development, clinical development, quality assurance, new business development and regulatory authorities. Certifications: Course Agenda: Day 1 General introduction to the PRC and the pharmaceutical market P.R. China - Drug Regulatory Systems P.R. China - Clinical Product Development Hong Kong SAR Macau SAR Day 2 P.R. China - Regulatory Strategies P.R. China - Health Authority Interactions P.R. China - Maintenance Taiwan (Republic of China) P.R China - Recent Developments For more information about this training course visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: ASIA PACIFIC CHINA HONG KONG MACAU TAIWAN INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 05/12/2025 09:46 AM/DISC: 05/12/2025 09:46 AM
