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Selection of Regulatory Starting Materials: New Guidelines and Recent Trends

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  • Timothy J.N. Watson, Ph.D. (Pfizer)

    Dr. Watson was one of the PhRMA expert working group (EWG) members on the ICHQ11 regulatory guidance document for drug substance, and the Rapporteur for the ICHQ11 Q&A Starting Material IWG. He also served on the ICHQ7 IWG Q&A team, ICHQ3C EWG, and supported many other ICH efforts (such as Q12). Tim is also one of Pfizer’s participating Boards of Directors for the International Consortium for Innovation and Quality (IQ) and serves as the Co-Chair of the ISPE Global RCC – North American Regional Focus Group. Tim’s primary responsibility at Pfizer is to collaborate with regulatory CMC team leaders, co-development teams (technical teams), and Pfizer Global Supply (PGS) teams on a number of regulatory and technical issues. He helps provide strategy with an impact across Pfizer’s portfolio, including quality by design (QbD), control strategy, criticality analysis, ICH expertise, review of relevant draft guidelines and regulations, and regional advocacy.

July 27, 2017
Thu 12:30 PM EDT

Duration 1H 30M

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