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The world is undergoing significant evolution and for regulatory professionals to stay competitive in the marketplace, they need access to tools and resources to help navigate today’s shifting regulatory landscape and adapt processes and to these ever-changing times.

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Adapting to change is critically important in today’s evolving regulatory environment and it is even more imperative than ever for regulatory professionals to proactively manage regulatory transformation in order to develop and implement successful global regulatory strategies.

Articles

Changing Global Regulatory Landscape and Strategy for Drug and Device Operations 29 July 2019
EU Accelerated Pathways 25 July 2019 (member exclusive)
Modernizing Canada’s Medical Nutrition Regulations for Food: What can be learned from international frameworks? 24 June 2019 (member exclusive)
Regulatory Challenges in Medical Foods: Natural Variations in Ingredients of Agricultural Origin 17 June 2019 (member exclusive)
Update on the Regulatory Status of Cannabidiol in Food and Dietary Supplements and Future Prospects 12 June 2019 (member exclusive)

Books

Global Medical Device Regulatory Strategy (Hardcover)
Global Pharmaceutical and Biologics Regulatory Strategy (Hardcover)

Online Courses

Global Regulatory Strategy for Medical Devices
Global Regulatory Strategy for Pharmaceuticals
Globalization of Clinical Research Trials and Investigations

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It is vitally important for regulatory professionals to stay abreast of global regulatory requirements and changing international standards, regulations and harmonization efforts in order to develop new processes to meet the needs of today’s evolving landscape. How will Brexit, EU MDR and EU IVDR and agency changes impact your current role?

Articles

China NMPA Publishes new Guidance Relating to Regulatory Inspection and Analytical Testing Documentation 23 July 2019 (member exclusive)
India’s New Drugs and Clinical Trials Rules: An Industry Perspective 19 July 2019 (member exclusive)
Microbiome, Personalized Nutrition 2 July 2019 (member exclusive)
The Botanical Safety Consortium (BSC): The Development of a 21st Century Framework for Assessing the Safety of Botanical Dietary Supplements 25 June 2019 (member exclusive)
Dietary Supplements and Public Safety: A Defense of DSHEA’s Three-Legged Stool 20 June 2019 (member exclusive)
Severe Acute Malnutrition (SAM): The Value of a Ready to Use Therapeutic Food (RUTF) Guideline 14 June 2019 (member exclusive)
The Critical Role of Thickeners in the Therapeutic Medical Management of People with Dysphagia 6 June 2019 (member exclusive)
US and EU Veterinary Medical Device Overview: Introduction of the IVDs for Veterinary use in Europe 29 March 2019 (member exclusive)
Global Planning and Submission Considerations for Animal Drugs 14 March 2019 (member exclusive)
The State of the Chinese Pharmaceutical Market 12 March 2019 (member exclusive)
The New Fast Marketing Authorisation Approval Program in China 11 March 2019 (member exclusive)
SAKIGAKE Designation in Japan 5 March 2019 (member exclusive)
New Zealand Looking Toward a New Regulatory Regime for Therapeutic Products 4 March 2019 (member exclusive)
Integrated Quality System in Israel: GMP, GDP and Everything in Between 3 January 2019 (member exclusive)

On-Demand Webcasts

Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets
Beyond Translation: The Centralised Procedure

Online Courses

Globalization of Clinical Research Trials and Investigations
Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview
Medical Devices: Canadian Regulations
Medical Devices: EU Regulations

Sponsored Webcasts

PMS Requirements of the EU MDR: Implementation Challenges and Solutions

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Staying up to date on regulatory trends and hot topics is critically important in today’s shifting global landscape. Guide your staff and organization through this regulatory evolution and explore available resources to help you interpret the challenges and implement strategies to meet your business objectives.

Articles

Navigating a Dynamic Regulatory Landscape in the Age of Artificial Intelligence (AI): FDA's approach to AI and Machine Learning 30 May 2019 (member exclusive)
The African Pharmaceutical and Medical Industry: Growth Factors 6 May 2019 (member exclusive)
Regulatory Pathways for Orphan/Rare Pediatric Diseases: Global Overview 29 March 2019 (member exclusive)
The Changing Landscape of Drug Promotion in a Digital World and What it Means for Regulatory Reviewers 18 January 2019 (member exclusive)

On-Demand Webcasts

Emerging Technology and Analytics in Risk Management
Successfully Integrating Cybersecurity Risk Management into International Regulatory Submissions

Online Courses

Regulation of IVDs for Key International Markets           
FDA Law and Regulation