Regulatory clearance is a prerequisite for manufacturers to get access to new markets and, in our experience in the Latam market, it is the weakest link in the product supply chain as regulatory is a key but usually overlooked area.
Latin America is usually seen as a whole from the commercial point of view (LatAm), but it is not a uniform region in relation to the regulatory framework. Aspects to consider vary from License holding concerns to documents, processes and local healthcare regulations differences between the various countries in this region.
Disregarding the regulatory issues may imply significant risks for companies that wish to enter the regional market.
Although there are different regional trade agreements in force; these agreements do not comprise all countries in Latin America nor have a direct correspondence with a single regulatory clearance or framework as it happens in the European Community and its Medical Devices Regulations applicable throughout the Community and the CE marking. Thus, the LatAm region poses a challenge for medical devices registration as each country has its own regulatory legislation or its particular way to apply the same legislation.
Knowing how to develop an effective Regional Regulatory Strategy and implement a Centralized Regional Management is an essential skill to be successful.
Expertise and knowledge on recently implemented Technovigilance legislations are also important to maintain the products in existing markets complying with local requirements.
In this Session, experts will take you through the process of developing a regional premarket and postmarket Regulatory Strategy in the Latam region. Since relevant knowledge and expertise in this area is scarce for regulatory affairs professionals, this session will provide you the tools/skills required to match regulatory timeframes with commercial timeframes and avoid losing business opportunities while minimizing risks.
Russian and other CIS markets were traditionally hard to achieve for foreign manufacturers due to the lack of available information in open sources resulting in misunderstanding of local regulations. Moreover each member state of CIS has own national registration rules which are unique and even presence in one of the market doesn't make registration procedure easier in other union member states. On 31 December 2019 was issued first registration certificate according to single market of Eurasian Economic Union (ARM, BLR, KAZ, KYG, RUS) regulations. This session will discuss strategic approaches how to obtain approval in all EEU member states in frame of one registration procedure with least possible trouble. The session will include the description of the most important stages in frame of approval procedure: pre-clinical trials requirements, QMS audit procedure, appropriate clinical trials strategy. In addition, how to comply with post registration requirements.
Define appropriate EEU classification
Describe approval procedure
Conduct trials on the base on local accredited labs and clinical sites
Gain knowledge about regulatory frameworks of different countries in the LatAm region addressing pre-marketing and post-marketing critical issues.
Describe the most significant challenges of regulatory clearance in the region and how to address them.
Discuss the importance of setting a Regional Regulatory strategy & implementing a centralized management of regulatory affairs in LATAM.