November 4-6, 2019 | North Bethesda, MD

Science and Regulatory Learning Track

GRx+BIOSIMS
SCIENCE AND REGULATORY
LEARNING TRACK

Stay Informed on Sciences and Regulatory Issues
Our science and regulatory affairs track will give you the insights you need to better navigate the regulatory landscape, and increase your understanding of how our industry can better manage the GDUFA II framework. Plus, be a part of in-depth discussions among diverse stakeholders – industry, academia and the FDA.

GRx+Biosims Science and Regulatory Learning Track:

Emerging Technologies: How Can the Generic Industry Participate and Benefit?
What does the new emerging technology landscape look like in the pharmaceutical manufacturing sector? FDA has published several guidances to encourage and facilitate the adoption of emerging technologies, all part of the Agencies efforts to advance new innovations. This session will describe what some of the technologies being utilized today are, how industry can participate in these initiatives and how the generic industry can benefit from the adoption of these processes as well as engage with FDA.

Technologies that are Impacting Our Industry
What are the technologies today that are influencing the way we do business? In recent years there have been significant developments that have made our business safer, better, and more efficient. In this session, we’ll discuss what some of those technologies are from  ensuring the safety of our supply chain to more efficiently managing labeling review, to submission preparation. These experts will be sharing their experience and ways to optimize in your own organizations.

Imminent Approvals – Enhancing Access
As industry and the FDA work together to streamline and improve processes, this session focuses on how determinations are made on imminent approval or tentative approval applications. This information session will go over specific situations with the GDUFA II commitment letter, including the provisions that are currently slowing down approvals and the metrics that can better ensure success of the generics user fee program. This illuminating session will provide greater insight into how the agency determines which application could fit the profile of an imminent approval or tentative approval application. Learn from FDA subject matter experts and industry colleagues on how we have worked together to instituted best practices to facilitate the agency’s ability to utilize imminent approval within the commitment letter to facilitate patient access to more affordable generic medicines.

Imminent Approvals – Enhancing Access
As industry and the FDA work together to streamline and improve processes, this session focuses on how determinations are made on imminent approval or tentative approval applications. This information session will go over specific situations with the GDUFA II commitment letter, including the provisions that are currently slowing down approvals and the metrics that can better ensure success of the generics user fee program. This illuminating session will provide greater insight into how the agency determines which application could fit the profile of an imminent approval or tentative approval application. Learn from FDA subject matter experts and industry colleagues on how we have worked together to instituted best practices to facilitate the agency’s ability to utilize imminent approval within the commitment letter to facilitate patient access to more affordable generic medicines.

Acquisitions/Licensing and Mergers – What Are the Regulatory Requirements and Strategies to Consider?
Hardly a day goes by when we don’t hear about another acquisition, merger or licensing agreement in our industry. With all this change, managing the complex regulatory environment is key to preventing drug shortages, maintaining compliant submissions and ensuring smooth transitions. This session addresses key regulatory considerations, including due diligence, ownership/site transfers, compliance issues, ensuring product supply and more.

Drug Substance and Drug Product Manufacturers- Partnering to Improve the Process
Agency guidance and information available to industry has improved the quality, submission and review of DMFs. However, deficiencies resulting from the Agency review of those DMFs, multiple ANDA references to the same DMF and basic communication between API manufacturers and ANDA holders still may create challenges in timely ANDA approval. In this session, industry and the Agency will discuss common challenges and deficiencies and ways to address them to ensure ANDA approvals meet GDUFA goals.

Office of Business Informatics and Office of Pharmaceutical Quality: FDA Study Data Standard for Submissions and Electronic Submissions Update – What Sponsors Need to Know
This highly useful presentation covers a wide range of issues, including study data guidance dates, study data technical rejection criteria and the self-check worksheet. It will also address metrics and analysis of TRC error rates, with an emphasis on the 70% error rate for ANDAs as well as typical errors seen during analysis and the best way to avoid them. We’ll cover eCTD (guidance, metrics, common errors and submission processing challenges) and introduce a new way of requesting pre-assigned application numbers via the CDER NextGen Portal (pre-assignment process, ease of use, automated confirmation and historical records).

Drug/Device Combination Products, Challenges and Opportunities
By definition, combination products are considered complex drugs. The dynamics of the review, as well as the information that must be included to support these applications, make them even more complicated and challenging. This session addresses how OGD, OPQ and CDRH work together to coordinate the review process and the challenges they face. In addition, we’ll review some of the key agency findings during the review process and how to better anticipate problems and concerns.

Labeling Best Practice and Strategies for First Pass Labeling Reviews
Label development, maintenance and compliance are integral parts of the regulatory pre- and post-approval process. Understanding how FDA manages label review under GDUFA II can increase your odds of approval. Additionally, maintenance against RLD updates and compliance are very important in the post approval environment. This session sheds light on the FDA system for managing label review and provides effective strategies to prevent common errors.

Post Approval Changes: Best Practices and Strategies
Today’s post-approval world is complex. There are many business decisions such as new equipment and technology, facility build outs, product transfers due to the relocation of manufacturing facilities or even revisions for older products due to changes in manufacturing and analytical technology that result in the need for global complex post approval changes.. This session delivers some best practices and effective strategies in working with  FDA for guidance and approval of complex changes.

Developing Complex Generic Products, How to Ensure Success!
The FDA has provided several ways for companies to interact to fast-track development, submission, approval and accessibility of complex generic products. Engage with our knowledgeable panel on key topics, discuss common challenge and learn the most important factors when developing a complex generic product.

Assessment of Risks, Challenges and Opportunities in Conducting Foreign Bioequivalence Studies
With the increasing globalization of the drug industry, how biosimilars are tested and regulated in different countries can drastically affect access and costs. That’s one of the reasons it’s more important than ever to come up with standard global development strategies that allow generic companies to save time and costs in research and development and which allows them to offer better prices for their products. This session can help you navigate the challenges and risks of contracting overseas studies, comparing scenarios of pharmacokinetics-based and clinical endpoint-based BE studies and hear the ins and outs of conducting foreign BE studies.

Controlled Correspondence: The Evolution and Opportunity
The Controlled Correspondence process has evolved over the years, particularly following the advent of GDUFA. Today the submission process is more structured and efficient resulting in shorter turnaround times and improved predictability of response timing. However, in many aspects, the process is more complex than ever and has created new challenges in obtaining necessary feedback.

One area of particular concern is Q1/Q2 Controlled Correspondence requests. For years, the Agency’s process allowed for a generic sponsor to propose up to three different formulations in one Q1/Q2 controlled correspondence. If none were deemed to be Q1/Q2, the Agency’s responses hinted at required adjustment. Today’s responses to Q1/Q2 inquiries now provide only acceptance or rejection of the three proposed formulations without further detail, making it much more difficult for generic sponsors to adjust their formulations toward the Q1/Q2 goal.

This session brings together industry and FDA representatives to cover the spectrum of sponsor experiences with Controlled Correspondences and address common mistakes/issues and how they can be avoided.

What’s Up with FDA’s Integrated Facility Evaluation Processes?
The quality and safety of drugs is of utmost importance; however, some of the changes FDA has made in its integrated facility evaluation processes have caused confusion with manufacturers. This informative session will provide plenty of answers as our panel delves into key topics related to drug inspections and FDA’s integrated approach to facility evaluations. In addition, we will wade further into inspection readiness to address some of the common inspectional issues including data integrity, investigations, CAPAs, quality agreements and aseptic processing.

Who should attend:

About GRx+Biosims 2019

GRx+Biosims 2019 is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory, policy and legal professionals. Top officials and subject matter experts share their knowledge and best practices to help attendees understand how to succeed in generic and biosimilar development, the regulatory process and approvals and the evolving policy landscape.

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Whether you are an AAM member, general attendee, speaker or exhibitor, you can be part of the premier scientific and regulatory conference for the U.S. generics and biosimilars industry.